Central Lab Manual

Central Laboratory
Services Manual
AstraZeneca UK Limited
Protocol: D361EC00001
Labcorp Project #: 524790

Region: North America
Version: 1.0.0
Manual Created:
22 January 2022
524790_TMEA Manual Created: 22 Jan 22 Page 1 Manual Revised: N/A Version 1.0.0
TABLE OF CONTENTS
History of Change
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English_TableOfContents_Update: 20220122 ŽƉǇƌŝŐŚƚΞϮϬϮϭ>ĂďŽƌĂƚŽƌǇŽƌƉŽƌĂƟŽŶŽĨŵĞƌŝĐĂΠ,ŽůĚŝŶŐƐ͘ůůƌŝŐŚƚƐƌĞƐĞƌǀĞĚ͘
IN F ORM A TI ON N O T IC E
LAB C OR P C EN TR A L L AB OR AT OR Y S ER VI C ES
E FF E CT IV E J UN E 2 02 1
Branding Update Regarding

Materials
As we entered 2021, we announced our plans to transition from Covance to the Labcorp brand name —
showcasing our unique combination of drug development and diagnostic capabilities through one
powerful, unified brand. Beginning in the end of June 2021, Covance by Labcorp will be known globally as
Labcorp Drug Development.
Although our name is changing, your studies will continue to be delivered by the same talented,
committed teams, on the same scientific instruments, with the same tireless commitment to patients.
As our new branding and name is deployed, we will be phasing out any remaining items that have the
Covance name and logo. During this transition period, you may still receive some items with the Covance
name and logo in combination with our new Labcorp Drug Development branding and logo. This includes
but is not limited to collection, packaging, and shipping materials, your investigator manual, and other
training documents. As such, some investigator manuals and other training documents created before the
name change may bear the Covance name and branding while the translation of those same materials
may bear the new name and branding if they were completed after the name change. Over time, new
items will fully transition to the new branding and bear the new name and logo.
Have additional questions? Contact our Investigator Support team by using the number for your location
that can be found in this manual.
Please retain a copy of this notice in your study files for documentation purposes.
labcorp.com
For Internal Use Only: All ෽ LN 50947 ෽ English ෽ 23June2021 ෽ WLK

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DATA PRIVACY NOTICE AND OPT OUT FOR FUTURE STUDIES
IMPORTANT: The policy and actions below pertain only to future clinical studies managed by Labcorp Central
Laboratory Services’s clinical development division. All other inquiries should be directed to the Labcorp Central
Laboratory Services Contact Numbers, listed towards the end of this manual. For Kit ordering, kit questions, and
kit inventory updates, please go to http://www.drugdevelopment.labcorp.com/kitordering.
If you do not wish for Labcorp Central Laboratory Services to retain your personal information for evaluation purposes
(see disclaimer below), please complete and send the below form to Labcorp Central Laboratory Services via e-mail
at xkb@Labcorp.com, via fax to [609.419.2840,] or via mail to [Labcorp Central Laboratory Services, 210 Carnegie
Center, Princeton, New Jersey 08540-6233 USA, c/o General Counsel]. Please note that this e-mail address should
not be used to contact Labcorp Central Laboratory Services for general inquiries, it is only used for the purpose
of managing your data for future studies. You may also contact Labcorp Central Laboratory Services via this e-mail
address if you: i) want to confirm the accuracy of the personal information Labcorp Central Laboratory Services has
retained about you; ii) would like to update your personal information; and/or iii) have any complaint regarding
Labcorp Central Laboratory Services’s use of your personal information.
I do NOT wish to be considered for future clinical studies, and I do NOT wish to be contacted by Labcorp
Central Laboratory Services for other clinical trials in the future.
* Investigator Name:
Institution Name (if applicable):
* Address:
* Town/City: * State/Province/Region:
* Postal Code: * Country:
* Telephone: * E-mail:
* - Required
I would like to UPDATE my personal information below, where I may be considered and contacted for
future clinical studies.
* Investigator Name:
Institution Name (if applicable):
* Address:
* Town/City: * State/Province/Region:
* Postal Code: * Country:
* Telephone: * E-mail:
* - Required
Disclaimer: Information about investigator performance in connection with the use and/or return of materials in any laboratory test kit will be
collected and used by Labcorp Central Laboratory Services and/or its affiliates to help evaluate clinical studies, investigators, and institutions for
future clinical studies. This information may be included in databases of Labcorp Central Laboratory Services and/or its affiliates for the purpose of
identifying skills, facilities and other information relevant to the performance of services for clinical trials. Labcorp Central Laboratory Services will
take reasonable steps to protect the security of such personal information retained; however such personal information may be transferred outside
of your country (including countries which may not have been assessed as having adequate privacy laws). Nevertheless, Labcorp Central Laboratory
Services takes reasonable steps to ensure that its affiliates, agents, subsidiaries and suppliers comply with its standards of privacy regardless of their
location.
English_LabPrivacy_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
LABCORP LABORATORY MANUAL VERSION RATIONALE
Labcorp Central Laboratory Services has a three digit version system in place for our laboratory manuals.
Third digit
First digit
Second digit
This version system takes sponsor requested updates, internally requested updates, and standard page
updates into account.
First Digit:
Sponsor requested updates: this occurs when the sponsor requests a change to the manual. As this digit
increases it will return the subsequent two digits to zero.
Second Digit:
Internal requested updates: this occurs with a Labcorp Central Laboratory Services related change to manual.
This digit will increase with each Labcorp Central Laboratory Services related change or return to zero with a
Sponsor requested change.
Third Digit:
Standard page updates: this occurs with a standard page change. This digit will increase with each standard
page related change or return to zero with a Sponsor requested change.
With the above as an explanation, here is an example.
Third digit, since the last sponsor

request there has been one
First digit, there has
Second digit, since the standard page update to the
been one sponsor
last sponsor request manual.
requested changes to
there have been three
this manual.
internal updates.
All changes will be accompanied by a Manual Revised date change. This information will be present on the cover of the
manual as well as the footer on all pages of the manual.
English_Version_Explanation_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
SECTION BREAK

L AB CO RP CENTRALL AB O R ATO RY SER VI CES

Welcome to Xcellerate® Lab

Investigator Portal
STUDYPREPARATION
XcellerateLabInvestigatorPortalisthedeliverymethodforstudy
laboratoryinformationincludingonͲscreenresults,labreports,alerts,
eQueries,trainingmaterials,laboratorymanuals,andsitecommunications.Herearesomekeythingsyouneedto
knowaboutthisapplication.
Access
1. NewuserswillreceiveaWelcomeEmailcontainingalinktothePasswordManager.
2. Newuserscanusethe“Clickhere”linkfromyourWelcomeEmailorgotoLoginScreenonXcellerateLab
InvestigatorPortalat:https://invp.covance.com
3. Entertherequiredfieldstoreceiveanemailcontainingalinktoreset/createyourpassword.
*Note:Thelinkisonlyvalidfor30minutesonceemailisreceived.
4. Entertherequiredfieldstocreateneworresetyourpassword.
x Minimumlength:8
x Maximumlength:32
x Atleastoneuppercaseletter
x Atleastonelowercaseletter
x Atleastonenumericcharacter
x Atleastonespecialcharacter
x Shouldnotcontainuser’sname
5. PasswordManagerwillsendaPasswordResetSuccessfulNotificationemail.
*Note:Passwordsexpirein90daycycles.YoucanreturntothePasswordManageratanygiventimein
thefuturetoresetyourpassword.
Training
XcellerateLabInvestigatorPortalusershaveavarietyoftrainingoptionsavailabletothemincludinggeneral
navigationtraining,quickreferenceguides,andarecordedlivedemo.Thesetrainingtoolsarelocatedunderthe
ApplicationTrainingtabwithintheportal.Reviewthisinformationinpreparationforyourfirstsubjectvisits.
NavigatingtheSystem
HomePage/Dashboard
ThehomepageprovidesaccesstostudyͲspecificdataanddocumentsviastudycards.TherearealsononͲ
studyspecificlinksatthetopofthepageforGeneralCommunications,GeneralLabManuals,GeneralTraining
MaterialsandApplicationTraining.UserSettingscanbereviewedormodifiedfromthedropͲdownmenuon
thehomepage.Lastly,linkstoimportantAnnouncementsandCommonLinksareavailableontherightsideof
thehomepage.
labcorp.com
StudyCards
EachstudycardprovideslinkstodocumentsincludingLabreports(alsoincludesResultAlerts,DataRevisions
andCancellations),LabManuals,SiteActions,Communications,TrainingMaterialsandeQueries.Foreach
category,thenumberofunreaddocumentswilldisplayonthestudycard.Clickingonthelinkwilltakeyou
directlytotheselectedcategorytab.Onceinthetab,youwillseeamenuontheleftsideofthescreenwhere
youcannavigatetothevariouscategoriesofstudyspecificinformation.
SetYourPreferencesinUserSettings
Whendocumentsarepostedtotheapplication,anemailisgenerated;preferencesbydefaultareIMMEDIATE
forResultAlertsandeQueries,andDAILYforallotherdocumenttypes.Threeemailpreferencesareavailable
foreachdocumenttype:Immediate,Daily,andNone.WerecommendthatyousetthepreferencetoDaily
withtheexceptionofResultAlertsandeQueriesinordertominimizethenumberofemailsreceived.
YoucanalsochooseyourdocumentlanguagepreferencesintheGeneraltabofUserSettings.Pleasenote
thatnotalldocumentsaretranslated;however,ifyouselectalanguageotherthanEnglish,anydocuments
translatedinyourselectedlanguagewillbedisplayedasyourdefault.
View,Filter,andPrintDocuments
Whenyouareinacategorypage(i.e.LabReports,LabManuals,etc.)unreaddocumentswillbeboldedand
theStatuswillbeunchecked.Ifanyuseratyoursitehasreadadocument,theStatuswillbechecked,butit
willremainboldeduntilyoureadit.Youcanhoveroveracheckmarkinthestatuscolumntoseewhoatyour
sitehasreadadocument.Youhavetheabilitytofilterforunreaddocumentsonly.Onceyoudownloada
document,theStatusischeckedandthelineisnolongerbolded.
Thereareoptionstoselectoneormultipledocumentsandtosaveorprinttheminbatches.More
informationisavailableinthenavigationtraining.
*Note:UsingthePreviewbutton(eyeicon)toreviewalabreportwillnotcountthedocumentasa“read”
report.Youmustdownloadthereporttocountasread.
OnͲScreenResults
ThisfeatureallowsaStandardTestResultview,SubjectviewandMicrobiologyviewofnearrealͲtimeaccess
tolabresultsinadditiontocustomizedtrendchartstoshowtrendsovertime.Whilethisfeaturedoesnot
replacetheLabReportsandAlertsandshouldnotbeusedforregulatorysubmission,itoffersaquickviewof
testresultsforefficientstudymanagement.
eQueries
Thisnewfeatureprovidestheabilityforsitestoreceiveandrespondtoquerieswithintheapplication
allowingforquickerissueresolution.Thenumberindicatoronthestudycardindicatesanyunresolved
queriesforyourstudy.AnImmediateemailnotificationwillbesenttoyoursitewhenaneweQueryis
opened.Forfurtherdetails,refertotheeQueryQuickReferenceGuidefoundwithintheApplicationTraining
tab.
Support
Needhelpwithtoolnavigation,contentinformation,usernameandpasswordresetsupport?Theseandmany
othertipscanbefoundintheApplicationTrainingtabatthetopofeveryscreen.Ifyoustillneedsupport,contact
theInvestigatorSupportTeam.
English_XcellerateWelcomeLetter_Update:20210810
HOLIDAY CONSIDERATIONS
Important considerations
Local courier service (pickup and delivery) may be limited prior to, during and following observed holidays
in the country to which you are shipping specimens. It is imperative that you check local service schedules in
advance of the holiday. Listed below are important considerations when planning your patient visits during
the holidays.
- Your courier service reserves the right to observe earlier than usual pick-up times during the holidays. Call your
courier service for local pick-up schedules.
- During the December/National holidays, schedule your pickups in advance of the holiday where possible.
- Call early in the day to schedule your pickup.
- When a holiday is observed on Monday, avoid laboratory collections on the preceding Saturday (i.e. Labor Day). (Not
applicable to Japan)
- Frozen specimens should NOT be shipped on the day before the observed holiday.
Send frozen specimens on the next available business day. (Not applicable to Japan)
- If shipping specimens on Friday, mark airway bill for Saturday delivery. (Not applicable for Japan)
- Specimens with short stabilities (eg. lymphocyte subsets, reticulocyte counts, etc.) should not be collected on the
day prior to the holiday. (Not applicable to Japan)
- For sites with 24 hours delivery time to Labcorp Central Laboratory Services, do not schedule any shipment 24 hours
before one of the dates on the next pages. (Not applicable for Japan)
- For sites with 48 hours delivery time to Labcorp Central Laboratory Services, do not schedule any shipment 48 hours
before one of the dates on the next pages. (Not applicable for Japan)
Holiday reminders are also available on the Labcorp Central Laboratory Services website:
https://drugdevelopment.labcorp.com/content/dam/covance/pdf/holidays.pdf
English_Custom Closed/Public Holidays North America 1/2_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
LABCORP CENTRAL LABORATORY SERVICES OBSERVED HOLIDAYS
US, Canada, and Puerto Rico (specimens sent to Indianapolis)
2021 2022 2023
01 January 01 January 01 January New Year’s Day

31 May 30 May 29 May Memorial Day
05 July 04 July 04 July Independence Day (Obs)
06 September 05 September 04 September Labor Day
25 November 1 24 November 1 23 November 1 Thanksgiving Day
25 December 25 December 25 December Christmas Day
For sites in US and Canada

If you ship specimens on a Thursday that is a holiday in the United States, you should mark “Saturday delivery”
on the airway bills.
1
Limited operations within Labcorp Central Laboratory Services this day due to Thanksgiving period.
English_Custom Closed/Public Holidays North America 2/2_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
CONTACT NUMBERS TO CALL LABCORP CENTRAL LABORATORY SERVICES

To call Labcorp Central Laboratory Services in Indianapolis from:
Monday: 07:00 am EST - 07:00 pm EST (Indianapolis time GMT-4)
Tuesday - Friday: 07:00 am EST - 08:00 pm EST (Indianapolis time GMT-4)
Saturday: 11:00 am EST - 07:00 pm EST (Indianapolis time GMT-4)
US, Canada, Puerto Rico 866-762-6209 (Toll Free)

317-271-1200 (Local calls)
317-616-2362 (Fax)
Courier Contact information can be found on the Investigator & Study Staff Website, along with Dangerous Goods
Training requirements and other important information:
https://drugdevelopment.labcorp.com/customers/investigators/investigator-study-team.html
English_Labcorp Central Laboratory Services Contact Numbers NorthAm_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
KIT INFORMATION
NOTE: To obtain the highest quality specimens possible, it is recommended all collection supplies
! be stored between 4°C to 25°C (39°F to 77°F). If an incident occurs where the storage conditions
for a lab kit are in question, contact your study Monitor or CRA. If you need to replace kits, contact
Covance Central Labs.
.LWV DUH SURWRFRO LQYHVWLJDWRU DQG YLVLW VSHFL¿F
Select the correct kit accordingly.
Please check kit expiration dates before using

the kit!
Some tubes used for the collection of samples have
expiration dates. These dates are defined by tube
manufacturers.
To ensure the validity of the tubes contained in the
collection kit, expiration dates are printed on the
outside of the kit box. The expiration date of each
kit corresponds to the shortest expiration date of
the tube(s) within the kit.
Please do not collect specimens in expired

containers!
Specimens received in an expired container which
includes an additive will be canceled as: “Sample
drawn in expired tube: Testing not performed.”
If you have expired tubes please use the online
web tool at http://www.covance.com/kitordering or
call Covance CLS to have these kits replaced and
your inventory updated. Note: Using the online tool
is the preferred method for tracking purposes.
A unique accession number is assigned to each kit

and its requisition form. Within the kit, specimen
containers and the requisition have the same
accession number (bar code).
Do not interchange the tubes and/or requisition

forms between kits!
Labeling samples with unique identifiers:

Complete the labels with appropriate identifiers
(screening number and/or patient number) using a
blue or black ball point or indelible ink pen.
Errors in specimen labeling cause delays in
reporting patient results and in some cases
require testing to be cancelled.
Each container label is pre-printed with a barcode

and an accession number.
Bulk Supplies
Depending on your protocol, additional items may
be provided. For some studies, no bulk supply is
provided.
Note: Information about investigator performance in connection with the use and/or return of materials in any laboratory
test kit will be collected and used by Covance and/or its affiliates to help evaluate clinical studies and to evaluate
investigators for future clinical studies.
English_Kit Information_Update: 20180430 ©2003-2018 /DEFRUS CLS
SUPPLY/RESUPPLY
In your initial shipment, you will receive a start-up supply of collection kits and shipping boxes/documents specific to your site and this
trial. A protocol-specific investigator manual can be found digitally on our Xcellence Investigator Portal.
For studies with automatic resupply
Required Scheduled Visits
When you use the first collection kit and complete the requisition, this becomes a patient-specific kit.
‫ ۈ‬+*) *-+ )/-' *-/*-4 -1$ .њ.- $+/*! #*!4*0-+/$ )/.њ‫ݦ‬-./1$.$/&$/Ѷ.(+' .я*0-0/*(/$- .0++'4.4./ (
sets up a future kit resupply schedule based on the visit testing schedule provided to us by your sponsor.
‫ ۈ‬This schedule is set up to “trigger” a resupply of kits approximately 21 days prior to the need at your site. This will allow for production
and delivery time (within 7 days of visit) to your site.
‫ ۈ‬The auto resupply system reviews our record of your site inventory each day for any activity, (e.g., kits sent in or kits shipped out).
• Accurate site inventory in the Labcorp Central Laboratory Services database is vital for optimal automatic resupply success.
• Important that you keep Labcorp Central Laboratory Services informed of inventory changes such as lost, damaged or
expired kits.
• Visits that contain all frozen batch shipped samples (e.g., monthly or end of study, instead of day of collection)should be
monitored closely. The Labcorp Central Laboratory Services database does not recognize that the kit has been used until
it is received at Labcorp Central Laboratory Services.
Other visits
Some kits cannot be automatically re-supplied based on the visit test schedule.
‫ ۈ‬3(+' .- 1$.$/./#/*0-2$/#$)/# ‫ݦ‬-./2 &*!/# ./04*-/#*. /#/- 0).# 0' ѐ / ./*--'4 -($)/$*)&$/.ю
‫ ۈ‬These visits would be resupplied based on a minimum/maximum schedule.
• *- 3(+' $.$/У*0' ‫ )ݦ‬2$/#($)$(0(*!Х)(3$(0(*!Чю
• #$.( )./#/2# )4*0-.$/ $)1 )/*-4!*-$.$/У!''. '*2Х&$/.in our database, the auto resupply system would generate
ћ/-$"" -ќ*- -/*0$'4*0-$)1 )/*-4&0+/*Чю
# +- ȍ ͖) ' 1 '. ) 0./*($5 !*- 4*0- .$/ 4 *)//$)" /#
)1 ./$"/*- 0++*-/ )/ - / *-+ )/-' *-/*-4
-1$ .Ǹ
!4*0-.$/ $.#$"# )-*'' -*-.'*2 )-*'' -ǹ2 )%0.//# - .0++'4/*2*-&(*- ƙ$$ )/'4!*-4*0-) .Ǹ
Investigator sites need to actively monitor inventory of kits and shipping materials. Shipping supplies are not automatically
resupplied and must be ordered.
*- ,0 ./$/$*)'.0++'$ .я+' . *)///# ++-*+-$/ $/
)1 )/*-4 )/ -'$./ '*2ѐ
For sites in US, Canada, and Puerto Rico contact Kit Inventory Center in Indianapolis
.0++'4Ѱ+- ! -- ( /#*ѱѐ#//+.ѐѶѶ-0" 1 '*+( )/ю'*-+ю*(Ѷ&$/*- -$)"
#*) ѐ' . - ! -/* /$*)УѰ*''- *)//0( -.ѱ*!/#$. *-+ )/-' *-/*-4 -1$ .)0'ю
Refer to your Web resupply form for delivery days.

‫ ۈ‬Please note there will be an expedited fee for orders requested with less than the standard turn around time.
‫( ۈ‬$) -ѐ
!4*0- '*/ $)) 3/ ) '$1 -4- 4*0- '$1 -4(4/& '*)" -/#)/# ./)-/0-)-*0)/$( ю
**PLEASE NOTE: The preferred method of communication for all kit ordering, questions and kit inventory updates
included, is through the website. Go to the above link, select your region, complete ALL of Section A, comment box (for
questions) and security check. Section B only needs to be completed for kit orders. Labcorp Central Laboratory Services
is able to reply to your comments within the web based tool. **
English_Supply Resupply NorthAm_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.

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INVESTIGATOR ORDER NOTIFICATION SERVICE
Email Notifications
For each kit order, either from our automatic resupply system or via a site request, a notification email will be sent to the receiving
site’s supply recipient at the following times:
‫ݦ)* ۈ‬-(/$*)/#/)*- -#. )- / ю This email will provide a listing of the materials included in the order.
‫ݦ)* ۈ‬-(/$*) /#/ ) *- - #. ) .#$++ !-*( *-+ )/-' *-/*-4 -1$ .ю This email will include courier
information that will allow tracking of the shipment.
‫* ۈ‬-+)$/ .ѐ*)‫ݦ‬-(/$*) ($')*/$‫ݦ‬/$*).2$''*)'4 be sent for - -.- / and - -.) '' .
If kits are sent to your site via an import broker, the shipment confirmation e-mail will not be sent to you; shipment details will be
communicated from the broker.
Order Cancellation
In the event that an order is cancelled, a notification email will also be sent. Please note, the Investigator Order Notification emails as
well as other important Labcorp Central Laboratory Services communications will arrive in your inbox from Labcorp Central
Laboratory Services Communications@labcorp.com. This is not a monitored email box so any questions should be directed to your
local Labcorp Central Laboratory Services Investigator Support Team.
Opt-out Option
Additionally, the notification system has been designed with an opt-out option, which will allow recipients to decline receipt of the
emails if not wanted. If you do not wish to receive these email notifications in the future, please send an email to:
OrderNotificationOptOut@labcorp.com.
Please be aware that the mailbox is designed .*' '4 for stopping emails from being sent to a particular email recipient. The mailbox is not
monitored for questions.
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SECTION BREAK
LABORATORY VISIT SCHEDULE FOR PROTOCOL D361EC00001
Mandatory FFPE
Mandatory FFPE Mandatory FFPE Optional Tumor
VISIT NAME Screening Slides 6-30 Cycle 1 Day 1 GX Cycle 1 Day 2
Block Slides 1-5 (IHC) Biopsy
(NGS)
VISIT TYPE
RQ U U U U RQ U RQ
(RQ=Required, Opt=Optional, U=Unscheduled)
OCCURRENCE Day -28 to Day 0 - - - - Day 1 (± 2 days) - Day 2 (± 2 days)

KIT TYPE 1 T-1 T-2 T-3 T-7 2 T-6 3
ctDNA blood samples Specimen Type
CTDNA PROCESSING BASELINE Whole Blood X X
CTDNA PROCESSING NON-BASELINE Whole Blood
SM02/ CTDNA BASELINE Whole Blood X X
SM03/ CTDNA NON-BASELINE Whole Blood
CTC blood sample 1 (CellSearch)
CTC CELLSEARCH Whole Blood X
CTC blood sample 2 (EPIC Sciences)
CTC EPIC NA/LATAM Whole Blood
Capivasertib PK blood samples
AZD5363 PK 1HR POST Plasma X
AZD5363 PK PRE-DOSE Plasma
Circulating soluble factors blood sample
SM08/ CIRCULAT SOLUBLE FACTOR Plasma X X
Whole blood DNA sample (genomic markers)
SM06/ WHOLE BLOOD DNA Whole Blood X X
Whole blood RNA sample
SM07/ WHOLE BLOOD RNA PAXgene Blood RNA X X
Mandatory tumour sample for exploratory analysis
SM04/ ARCH/NEW FFPE H&E SLIDE Slides C
SM09/ ARCH/NEW FFPE BLOCK Block X
SM10/ ARCH/NEW FFPE SLIDES 1-5 Slides X
SM11/ PATHOLOGY REPORT Pathology Report C C C
SM16/ ARCH/NEW FFPE SLD 6-30 Slides X
Optional tumour biopsy
SM12/ SINGLE BIOPSY BLOCK Block C
SM13/ SINGLE BIOPSY SNAP Snap Biopsy C
Optional paired biopsy
SM14/ PAIRED BIOPSY BLOCK Block C
SM15/ PAIRED BIOPSY SNAP Snap Biopsy C
Genomics Initiative optional, exploratory genetic sample
SM01/ GX SAMPLE Whole Blood X
APH Administrative Questions
BIOPSY / RESECTION COLLECTION X X X X
BLOCK ID X X X
COLLECTION METHOD? X X X
DATE OF SLIDE SECTIONING X X
DIAGNOSIS? X X X
FIXATIVE USED? X X X
FORMALIN FIXATION TIME X X X
HOW MANY BLOCKS SUBMITTED? X
HOW MANY SLIDES SUBMITTED? X X
METASTATIC TUMOR LOCATION? X X X X
PRIMARY TUMOR LOCATION X X X X
SECTION MICRON THICKNESS? X X
TUMOR TYPE (BLOCK) X
TUMOR TYPE (SLIDES) X X
X Mandatory testing
C Conditional testing
English_Visit Test Schedule_Update: 20220122 ŽƉǇƌŝŐŚƚΞϮϬϮϭ>ĂďŽƌĂƚŽƌǇŽƌƉŽƌĂƟŽŶŽĨŵĞƌŝĐĂΠ,ŽůĚŝŶŐƐ͘ůůƌŝŐŚƚƐƌĞƐĞƌǀĞĚ͘
Every 16
CTC Epic Disease
VISIT NAME Cycle 1 Day 12 Cycle 2 Day 1 Cycle 3 Day 1 Cycle 5 Day 1 Weeks from Discontinuation
NA/LATAM Progression
D1C1
VISIT TYPE
RQ RQ RQ RQ U U U U
(RQ=Required, Opt=Optional, U=Unscheduled)
Day 12 (± 2 Day 22 (± 2 Day 64 (± 2 Day 85 (± 2
OCCURRENCE - - - -
days) days) days) days)
KIT TYPE 4 5 6 7 T-4 T-8 T-5 T
ctDNA blood samples Specimen Type
CTDNA PROCESSING BASELINE Whole Blood
CTDNA PROCESSING NON-BASELINE Whole Blood X X X X X X X
SM02/ CTDNA BASELINE Whole Blood
SM03/ CTDNA NON-BASELINE Whole Blood X X X X X X X
CTC blood sample 1 (CellSearch)
CTC CELLSEARCH Whole Blood X X
CTC blood sample 2 (EPIC Sciences)
CTC EPIC NA/LATAM Whole Blood X
Capivasertib PK blood samples
AZD5363 PK 1HR POST Plasma
AZD5363 PK PRE-DOSE Plasma X X X
Circulating soluble factors blood sample
SM08/ CIRCULAT SOLUBLE FACTOR Plasma X X X X X X
Whole blood DNA sample (genomic markers)
SM06/ WHOLE BLOOD DNA Whole Blood X X X X X X
Whole blood RNA sample
SM07/ WHOLE BLOOD RNA PAXgene Blood RNA X X X X X X
Mandatory tumour sample for exploratory analysis
SM04/ ARCH/NEW FFPE H&E SLIDE Slides
SM09/ ARCH/NEW FFPE BLOCK Block
SM10/ ARCH/NEW FFPE SLIDES 1-5 Slides
SM11/ PATHOLOGY REPORT Pathology Report
SM16/ ARCH/NEW FFPE SLD 6-30 Slides
Optional tumour biopsy
SM12/ SINGLE BIOPSY BLOCK Block
SM13/ SINGLE BIOPSY SNAP Snap Biopsy
Optional paired biopsy
SM14/ PAIRED BIOPSY BLOCK Block
SM15/ PAIRED BIOPSY SNAP Snap Biopsy
Genomics Initiative optional, exploratory genetic sample
SM01/ GX SAMPLE Whole Blood
APH Administrative Questions
BIOPSY / RESECTION COLLECTION
BLOCK ID
COLLECTION METHOD?
DATE OF SLIDE SECTIONING
DIAGNOSIS?
FIXATIVE USED?
FORMALIN FIXATION TIME
HOW MANY BLOCKS SUBMITTED?
HOW MANY SLIDES SUBMITTED?
METASTATIC TUMOR LOCATION?
PRIMARY TUMOR LOCATION
SECTION MICRON THICKNESS?
TUMOR TYPE (BLOCK)
TUMOR TYPE (SLIDES)
X Mandatory testing
C Conditional testing
SPECIALTY VISIT DEFINITIONS:
Kit - MANDATORY FFPE BLOCK

dŚŝƐŬŝƚǁŝůůďĞƵƐĞĚƚŽĐŽůůĞĐƚŵĂŶĚĂƚŽƌǇƚƵŵŽƵƌƐĂŵƉůĞĨŽƌĞǆƉůŽƌĂƚŽƌǇĂŶĂůǇƐŝƐĂƚ^ĐƌĞĞŶŝŶŐ͘WůĞĂƐĞƵƐĞƚŚŝƐŬŝƚŝĨďůŽĐŬƐĂƌĞƐƵďŵŝƩĞĚ͘
Kit - MANDATORY FFPE SLIDES 1-5 (IHC)

This kit will be used to collect mandatory tumour sample for exploratory analysis at Screening.
WůĞĂƐĞƵƐĞƚŚŝƐŬŝƚŝĨƐůŝĚĞƐĂƌĞƐƵďŵŝƩĞĚ͘WůĞĂƐĞĂůƐŽĐŽůůĞĐƚDEdKZz&&W^>/^ϲͲϯϬ;E'^ͿŬŝƚ͘
Kit - MANDATORY FFPE SLIDES 6-30 (NGS)

This kit will be used to collect mandatory tumour sample for exploratory analysis at Screening.
WůĞĂƐĞƵƐĞƚŚŝƐŬŝƚŝĨƐůŝĚĞƐĂƌĞƐƵďŵŝƩĞĚ͘WůĞĂƐĞĂůƐŽĐŽůůĞĐƚDEdKZz&&W^>/^ϭͲϱ;/,ͿŬŝƚ͘
Kit - Every 16 Weeks from D1C1

This kit is used to collect SM/CTDNA every 16 weeks from D1C1.
<ŝƚͲ'ĞŶĞƟĐ;'yͿ
dŚŝƐŬŝƚŝƐƵƐĞĚƚŽĐŽůůĞĐƚƚŚĞŽƉƟŽŶĂů'ĞŶĞƟĐƐĂŵƉůĞĂƚǇĐůĞϭĂǇϭ͘
Kit - OPTIONAL TUMOUR BIOSPY

This kit can be used to collect single biopsy or paired biopsy:
– If used to collect paired biopsy, use this kit at pre-dose on C1D1 (window of up to 28 days prior to C1D1 allowed) and an
on-treatment biopsy taken between C1D17 and C1D19.
– If used to collect single biopsy, use this kit at Disease Progression only.
Kit - DISCONTNUATION
dŚŝƐŬŝƚŝƐƵƐĞĚĂƚĚŝƐĐŽŶƟŶƵĂƟŽŶ͘
Kit - DISEASE PROGRESSION

This kit is used at progression.
Kit - CTC EPIC NA/LATAM

This kit is used to collect CTC Blood sample (Epic Science).
This kit should be collected pre-dose at Cycle 1 Day 1 and Progression.
STUDY SPECIFIC NOTES:
^ƉŽŶƐŽƌŝƐĐŽůůĞĐƟŶŐϬϭͲ:ƵůĂŶĚƚŚĞƐƵďũĞĐƚ͛ƐďŝƌƚŚǇĞĂƌĂƐƚŚĞĚĂƚĞŽĨďŝƌƚŚ;KͿĨŽƌĂůůƐƵďũĞĐƚƐŝŶƚŚŝƐƐƚƵĚǇ͘>ĂďŽƌƉ>^ƌĞĨĞƌĞŶĐĞ
ƌĂŶŐĞƐ͕ĂůĞƌƚƐ͕ŇĂŐƐĂŶĚĂŐĞͲĚĞƉĞŶĚĞŶƚĐĂůĐƵůĂƟŽŶƐǁŝůůďĞďĂƐĞĚŽŶƚŚĞŐĞŶĞƌŝĐKƉƌŽǀŝĚĞĚďǇƚŚĞŝŶǀĞƐƟŐĂƚŽƌ͘/ƚŝƐƚŚĞƌĞƐƉŽŶƐŝďŝůŝƚǇ
ŽĨƚŚĞŝŶǀĞƐƟŐĂƚŽƌƚŽĞŶƐƵƌĞƚŚĞƐĞƉĂƌĂŵĞƚĞƌƐĂƌĞĂůŝŐŶĞĚǁŝƚŚƚŚĞƌĞĂůƐƵďũĞĐƚĂŐĞĂŶĚƚŚĂƚƚŚĞƐƵďũĞĐƚŵĞĞƚƐƚŚĞĂŐĞƌĞƋƵŝƌĞŵĞŶƚ
for the study.
^DϬϭͬ'Ed/;'yͿďůŽŽĚƐĂŵƉůĞĐĂŶďĞĐŽůůĞĐƚĞĚĂƚǇĐůĞϭĂǇϭ͕ŽƌĂŶǇǀŝƐŝƚƵŶƟůƚŚĞůĂƐƚƐƚƵĚǇǀŝƐŝƚ͘
SPECIMEN COLLECTION PROCEDURES FOR PROTOCOL D361EC00001
Some immunoassay tests may exhibit interference when samples are collected from a person who is consuming a supplement with
ĂŚŝŐŚĚŽƐĞŽĨďŝŽƟŶ;ĂůƐŽƚĞƌŵĞĚĂƐǀŝƚĂŵŝŶϳŽƌϴ͕ǀŝƚĂŵŝŶ,͕ŽƌĐŽĞŶǌǇŵĞZͿ͘/ƚŝƐƌĞĐŽŵŵĞŶĚĞĚƚŽĂƐŬƉĂƟĞŶƚƐĂďŽƵƚďŝŽƟŶ
ƐƵƉƉůĞŵĞŶƚĂƟŽŶ͘WŚǇƐŝĐŝĂŶƐƐŚŽƵůĚďĞĂǁĂƌĞƚŚĂƚŚŝŐŚůĞǀĞůƐŽĨďŝŽƟŶƐƵƉƉůĞŵĞŶƚĂƟŽŶŵĂǇŚĂǀĞĂŶŝŵƉĂĐƚŽǀĞƌĂƉĞƌŝŽĚŽĨĂƚ
ůĞĂƐƚϳϮŚŽƵƌƐ͘^ĞĞƚŚĞůŝƐƚŽĨĂƐƐĂǇƐǁŝƚŚƉŽƚĞŶƟĂůŝŶƚĞƌĨĞƌĞŶĐĞŝŵŵĞĚŝĂƚĞůǇĨŽůůŽǁŝŶŐƚŚĞƐƉĞĐŝŵĞŶĐŽůůĞĐƟŽŶƉƌŽĐĞĚƵƌĞƐ͘
PLASMA
TESTS VISITS COLLECT RETURN

Cycle 1 Day 12, FROZEN
AZD5363 PK PRE-DOSE Cycle 2 Day 1, ͳϮϬΣ
Cycle 3 Day 1 MONTHLY
AZD5363 PK 1HR POST Cycle 1 Day 2 1 x 2.0 mL lavender top 1 x cryovial

AZD5363 PK 2HR POST Cycle 1 Day 2 EDTA tube TO: LABCORP CLS
AZD5363 PK 4HR POST Cycle 1 Day 2
^ĂŵƉůĞƐĂƌĞĐŽůůĞĐƚĞĚĂƚƚŚĞƟŵĞŝŶƚĞƌǀĂůƐƉƌĞƐĞŶƚĞĚŝŶƚŚĞƉƌŽƚŽĐŽů͘tŚŽůĞďůŽŽĚǁŝůůďĞĐŽůůĞĐƚĞĚŝŶϮŵ>sĂĐƵƚĂŝŶĞƌƚƵďĞƐ
ĐŽŶƚĂŝŶŝŶŐ<ϮdĂƐĂŶƟͲĐŽĂŐƵůĂŶƚĨŽƌƚŚĞĂŶĂůǇƐŝƐŽĨϱϯϲϯ͘
ϭ͘ &ŽůůŽǁŝŶŐĐŽůůĞĐƟŽŶ͕ŐĞŶƚůǇŝŶǀĞƌƚƚŚĞƐĂŵƉůĞƐϭϬƟŵĞƐĂŶĚŝŵŵĞĚŝĂƚĞůǇƉůĂĐĞŽŶŝĐĞ͘
^ĂŵƉůĞWƌŽĐĞƐƐŝŶŐ͘
Ϯ͘ tŝƚŚŝŶϯϬŵŝŶƵƚĞƐŽĨďůŽŽĚĐŽůůĞĐƟŽŶĐĞŶƚƌŝĨƵŐĞĂƚϭϱϬϬŐ͕ĂƚϰΣĨŽƌϭϬŵŝŶƵƚĞƐ;ŝĨƌĞĨƌŝŐĞƌĂƚĞĚĐĞŶƚƌŝĨƵŐĞŝƐƵŶĂǀĂŝůĂďůĞ͕ŽŬ
ƚŽĐĞŶƚƌŝĨƵŐĞĂƚƌŽŽŵƚĞŵƉĞƌĂƚƵƌĞͿ͘&ƌŽŵĞĂĐŚϮŵ>ďůŽŽĚƐĂŵƉůĞ͕ƚƌĂŶƐĨĞƌƚŚĞƌĞƐŝĚƵĂůƉůĂƐŵĂŝŶƚŽĂϮŵ>ƐĐƌĞǁͲĐĂƉĐƌǇŽǀŝĂů
ƵƐŝŶŐĂĚŝƐƉŽƐĂďůĞƉŽůǇƉƌŽƉǇůĞŶĞƉŝƉĞƩĞ͘
ϯ͘ ^ƚŽƌĞƉůĂƐŵĂƐĂŵƉůĞƐĂƚͲϮϬΣŝŶĂŶƵƉƌŝŐŚƚƉŽƐŝƟŽŶǁŝƚŚŝŶϯϬŵŝŶƵƚĞƐŽĨƉůĂƐŵĂƉƌĞƉĂƌĂƟŽŶĂŶĚŬĞĞƉĨƌŽǌĞŶĂƚƚŚŝƐƚĞŵƉĞƌĂƚƵƌĞ
ƵŶƟůƐŚŝƉŵĞŶƚƚŽ>^;ŝĨͲϮϬΣĨƌĞĞǌĞƌŝƐƵŶĂǀĂŝůĂďůĞ͕ŽŬƚŽĨƌĞĞǌĞĂƚͲϳϬͬͲϴϬΣƵŶƟůƐŚŝƉŵĞŶƚƚŽ>ĂďŽƌƉͿ͘
ϰ͘ ^ŚŝƉƐĂŵƉůĞƐĨƌŽǌĞŶŽŶĚƌǇŝĐĞƚŽ>ĂďŽƌƉ>^ŵŽŶƚŚůǇ͘
PLASMA

FROZEN
ͳϮϬΣKZ>Kt
^DϬϭͬ'y^DW> 'y MONTHLY
1 x 6.0 mL lavender top EDTA tube
TO: LABCORP CLS
ϭ͘ ƌĂǁϲŵ>ŽĨďůŽŽĚŝŶĂůĂǀĞŶĚĞƌƚŽƉ<ϮdƚƵďĞ;ŵĂǆŝŵƵŵǀŽůƵŵĞͿ͘
Ϯ͘ DŝǆŝŵŵĞĚŝĂƚĞůǇďǇŐĞŶƚůĞŝŶǀĞƌƐŝŽŶϴʹϭϬƟŵĞƐ͘KEKd^,<͘
ϯ͘ &ƌĞĞǌĞŝŵŵĞĚŝĂƚĞůǇĂƚͲϮϬΣŽƌďĞůŽǁ͘
ϰ͘ KEKdEdZ/&h'͘
ϱ͘ <ĞĞƉĨƌŽǌĞŶĂƚͲϮϬΣŽƌďĞůŽǁƵŶƟůƐŚŝƉŵĞŶƚ͘
ϲ͘ ^ŚŝƉĨƌŽǌĞŶŽŶĚƌǇŝĐĞƚŽ>ĂďŽƌƉ>^ŵŽŶƚŚůǇ͘
PLASMA

ScreeŶŝŶŐ͕ FROZEN
ͳϳϬΣ
Cycle 1 Day 1,
MONTHLY
Cycle 1 Day 12,
^DϬϴͬ/Zh>d Cycle 2 Day 1,
^K>h>&dKZ Cycle 3 Day 1, 1 x 4.0 mL lavender top 2 x cryovials
Cycle 5 Day 1, EDTA tube TO: LABCORP CLS
ŝƐĞĂƐĞWƌŽŐƌĞƐƐŝŽŶ͕
ŝƐĐŽŶƚŶƵĂƟŽŶ
ϭ͘ ƌĂǁŵĂǆŝŵƵŵǀŽůƵŵĞŽĨďůŽŽĚŝŶƚŽůĂǀĞŶĚĞƌƚŽƉ<ϮdƚƵďĞ͘
Ϯ͘ /ŵŵĞĚŝĂƚĞůǇŵŝǆďǇŐĞŶƚůĞŝŶǀĞƌƐŝŽŶϴƚŽϭϬƟŵĞƐ͘
ϯ͘ ŽŶŽƚƐŚĂŬĞ͘
ϰ͘ ĞŶƚƌŝĨƵŐĞǁŝƚŚŝŶϮŚŽƵƌƐŽĨĐŽůůĞĐƟŽŶĂƚϭϭϬϬŐͲϭϯϬϬŐĨŽƌϭϬŵŝŶƵƚĞƐĂƚƌŽŽŵƚĞŵƉĞƌĂƚƵƌĞ͘
ϱ͘ dƌĂŶƐĨĞƌĂƉƉƌŽǆ͘ϭŵ>ŽĨƉůĂƐŵĂŝŶƚŽĞĂĐŚϮŵ>ƚƵďĞ͘
ϲ͘ /ŵŵĞĚŝĂƚĞůǇĨƌĞĞǌĞƵƉƌŝŐŚƚĂƚͲϳϬΣ;ŽƌͲϮϬΣŝĨͲϳϬΣƐƚŽƌĂŐĞŶŽƚĂǀĂŝůĂďůĞͿ͘
ϳ͘ ^ŚŝƉƚŚĞƐĂŵƉůĞƐĨƌŽǌĞŶŽŶĚƌǇŝĐĞŵŽŶƚŚůǇ;ŽƌǁŝƚŚŝŶϮǁĞĞŬƐŝĨƐƚŽƌĞĚĂƚͲϮϬΣͿƚŽ>ĂďŽƌƉ͘
ΎKƉƟŽŶĂůͬŽŶĚŝƟŽŶĂůƚĞƐƟŶŐŽƌůůƚĞƐƟŶŐKƉƟŽŶĂůͬŽŶĚŝƟŽŶĂůĂƚsŝƐŝƚ͖ΎΎZĞŇĞǆƚĞƐƟŶŐ
ŶŐůŝƐŚͺ^ƉĞĐŝŵĞŶŽůůĞĐƟŽŶWƌŽĐĞĚƵƌĞƐͺhƉĚĂƚĞ͗ϮϬϮϮϬϭϮϮ ŽƉǇƌŝŐŚƚΞϮϬϮϭ>ĂďŽƌĂƚŽƌǇŽƌƉŽƌĂƟŽŶŽĨŵĞƌŝĐĂΠ,ŽůĚŝŶŐƐ͘ůůƌŝŐŚƚƐƌĞƐĞƌǀĞĚ͘
t,K>>KK
TESTS VISITS COLLECT / RETURN

ScrĞĞŶŝŶŐ͕ FROZEN
ͳϮϬΣKZ>Kt
Cycle 1 Day 1,
MONTHLY
Cycle 1 Day 12,
^DϬϲͬt,K>>KK Cycle 2 Day 1,
E Cycle 3 Day 1, 1 x 6.0 mL lavender top EDTA tube
Cycle 5 Day 1, TO: LABCORP CLS
ϭ͘ ƌĂǁϲŵ>ŽĨďůŽŽĚŝŶĂůĂǀĞŶĚĞƌƚŽƉ<ϮdƚƵďĞ;ŵĂǆŝŵƵŵǀŽůƵŵĞͿ͘
Ϯ͘ DŝǆŝŵŵĞĚŝĂƚĞůǇďǇŐĞŶƚůĞŝŶǀĞƌƐŝŽŶϴʹϭϬƟŵĞƐ͘KEKd^,<͘
ϯ͘ &ƌĞĞǌĞŝŵŵĞĚŝĂƚĞůǇĂƚͲϮϬΣŽƌďĞůŽǁ͘KEKdEdZ/&h'͘
ϰ͘ <ĞĞƉĨƌŽǌĞŶĂƚͲϮϬΣŽƌďĞůŽǁƵŶƟůƐŚŝƉŵĞŶƚ͘
ϱ͘ ^ŚŝƉĨƌŽǌĞŶŽŶĚƌǇŝĐĞƚŽ>ĂďŽƌƉ>^ŵŽŶƚŚůǇ͘
t,K>>KK

Cycle 1 Day 1, AMBIENT
DAY OF COLLECTION
CTC Cellsearch Cycle 5 Day 1,
ŝƐĞĂƐĞWƌŽŐƌĞƐƐŝŽŶ ϭǆϭϬ͘Ϭŵ>Ğůů^ĂǀĞƉƌĞƐĞƌǀĂƟǀĞƚƵďĞ TO: LABCORP CLS
WĂƟĞŶƚWƌĞƉĂƌĂƟŽŶ͗ůůŽǁĂƚůĞĂƐƚϳĚĂǇƐĂŌĞƌĂĚŵŝŶŝƐƚƌĂƟŽŶŽĨĚŽǆŽƌƵďŝĐŝŶďĞĨŽƌĞƐĂŵƉůĞĐŽůůĞĐƟŽŶ͘
EŽƚĞ͗hƐĞĂďƵƩĞƌŇǇŶĞĞĚůĞƐĞƚĨŽƌĐŽůůĞĐƟŽŶ͘
^ŝŶĐĞƚŚŝƐƚƵďĞĐŽŶƚĂŝŶƐĐŚĞŵŝĐĂůĂĚĚŝƟǀĞƐ͕ŝƚŝƐŝŵƉŽƌƚĂŶƚƚŽĂǀŽŝĚƉŽƐƐŝďůĞďĂĐŬŇŽǁĨƌŽŵƚŚĞƚƵďĞǁŝƚŚƚŚĞƉŽƐƐŝďŝůŝƚǇŽĨĂĚǀĞƌƐĞ
ƌĞĂĐƟŽŶƐ͘dŽŐƵĂƌĚĂŐĂŝŶƐƚďĂĐŬŇŽǁ͕ŽďƐĞƌǀĞƚŚĞĨŽůůŽǁŝŶŐƉƌĞĐĂƵƟŽŶƐ͗
ϭ͘ <ĞĞƉƚŚĞƉĂƟĞŶƚ͛ƐĂƌŵŝŶƚŚĞĚŽǁŶǁĂƌĚƉŽƐŝƟŽŶĚƵƌŝŶŐĐŽůůĞĐƟŽŶƉƌŽĐĞĚƵƌĞ͘
Ϯ͘ ,ŽůĚƚŚĞƚƵďĞǁŝƚŚƚŚĞƐƚŽƉƉĞƌƵƉƉĞƌŵŽƐƚƐŽƚŚĂƚƚŚĞƚƵďĞĐŽŶƚĞŶƚƐĚŽŶŽƚƚŽƵĐŚƚŚĞƐƚŽƉƉĞƌŽƌƚŚĞĞŶĚŽĨƚŚĞŶĞĞĚůĞĚƵƌŝŶŐ
ƐĂŵƉůĞĐŽůůĞĐƟŽŶ͘
ϯ͘ ZĞůĞĂƐĞƚŚĞƚŽƵƌŶŝƋƵĞƚŽŶĐĞďůŽŽĚƐƚĂƌƚƐƚŽŇŽǁŝŶƚŚĞƚƵďĞ͘
&ŝůůƚƵďĞƵŶƟůďůŽŽĚŇŽǁƐƚŽƉƐ͘/ŵŵĞĚŝĂƚĞůǇŵŝǆďǇŐĞŶƚůǇŝŶǀĞƌƟŶŐƚŚĞƚƵďĞϴƚŽϭϬƟŵĞƐƚŽŵŝǆƚŚĞďůŽŽĚǁŝƚŚƚŚĞĂĚĚŝƟǀĞ͘
^ƚŽƌĞƐĂŵƉůĞƐĂƚĂŵďŝĞŶƚƚĞŵƉĞƌĂƚƵƌĞƐŽĨϭϱͲϯϬΣ͘^ŚŝƉĂŵďŝĞŶƚ͘
t,K>>KK

AMBIENT
DAY OF COLLECTION
TO: Epic Sciences
ƩŶ͗;WĂƌƚŶĞƌWƌŽƚŽĐŽůη
dW/Eͬ>dD dƉŝĐEͬ>dD D361EC00001 / Epic Internal ID)
1 x 10.0 mL Streck Cell-Free DNA tube
9381 Judicial Dr., Suite 200
San Diego, CA 92121
USA
IMPORTANT:dŚĞĮƌƐƚϱŵ>ŽĨďůŽŽĚĐŽůůĞĐƚĞĚĨƌŽŵƚŚĞĨƌĞƐŚǀĞŶŝƉƵŶĐƚƵƌĞĐĂŶŶŽƚďĞƵƐĞĚĨŽƌƚŚĞĐŽůůĞĐƟŽŶŝŶƚŽƚŚĞ^ƚƌĞĐŬƚƵďĞƐ
ĚƵĞƚŽƉŽƐƐŝďŝůŝƚǇŽĨĐŽŶƚĂŵŝŶĂƟŶŐĞƉŝƚŚĞůŝĂůĐĞůůƐĚƵƌŝŶŐǀĞŶŝƉƵŶĐƚƵƌĞ͘WůĞĂƐĞĞŶƐƵƌĞƚŚĂƚĂƚůĞĂƐƚŽŶĞďůŽŽĚƚƵďĞŽĨϱŵ>ŽƌŵŽƌĞ
ŝƐĐŽůůĞĐƚĞĚƉƌŝŽƌƚŽĐŽůůĞĐƟŽŶŽĨƚŚĞdƐĂŵƉůĞƚŽĂǀŽŝĚĂĚǀĞƌƐĞůǇĂīĞĐƟŶŐƚŚĞƚĞƐƚƌĞƐƵůƚƐ͘
WƌĞǀĞŶƟŽŶŽĨĂĐŬŇŽǁ͗
^ŝŶĐĞ^ƚƌĞĐŬĞůůͲ&ƌĞĞEdƚƵďĞƐĐŽŶƚĂŝŶĐŚĞŵŝĐĂůĂĚĚŝƟǀĞƐ͕ŝƚŝƐŝŵƉŽƌƚĂŶƚƚŽĂǀŽŝĚƉŽƐƐŝďůĞďĂĐŬŇŽǁĨƌŽŵƚŚĞƚƵďĞ͘dŽŐƵĂƌĚ
ĂŐĂŝŶƐƚďĂĐŬŇŽǁ͕ŽďƐĞƌǀĞƚŚĞĨŽůůŽǁŝŶŐƉƌĞĐĂƵƟŽŶƐ͗
- <ĞĞƉƉĂƟĞŶƚ͛ƐĂƌŵŝŶƚŚĞĚŽǁŶǁĂƌĚƉŽƐŝƟŽŶĚƵƌŝŶŐƚŚĞĐŽůůĞĐƟŽŶƉƌŽĐĞĚƵƌĞ͘
- ,ŽůĚƚŚĞƚƵďĞǁŝƚŚƚŚĞƐƚŽƉƉĞƌƵƉƉĞƌŵŽƐƚ͘
- ZĞůĞĂƐĞƚŽƵƌŶŝƋƵĞƚŽŶĐĞƚŚĞďůŽŽĚƐƚĂƌƚƐƚŽŇŽǁŝŶƚŽƚŚĞƚƵďĞ͕ŽƌǁŝƚŚŝŶϮŵŝŶƵƚĞƐŽĨĂƉƉůŝĐĂƟŽŶ͘
- dƵďĞĐŽŶƚĞŶƚƐƐŚŽƵůĚŶŽƚƚŽƵĐŚƐƚŽƉƉĞƌŽƌƚŚĞĞŶĚŽĨƚŚĞŶĞĞĚůĞĚƵƌŝŶŐƚŚĞĐŽůůĞĐƟŽŶƉƌŽĐĞĚƵƌĞ͘
ůŽŽĚŽůůĞĐƟŽŶ/ŶƐƚƌƵĐƟŽŶƐ͗
ΎΎ^ĐŚĞĚƵůĞĐŽƵƌŝĞƌĨŽƌƐĂŵĞͲĚĂǇƐĂŵƉůĞƉŝĐŬͲƵƉƉƌŝŽƌƚŽĐŽůůĞĐƟŽŶ
- ŽŶĮƌŵďůŽŽĚƚƵďĞŝƐŶŽƚĞǆƉŝƌĞĚ͘ǆƉŝƌĞĚƚƵďĞƐƐŚŽƵůĚŶŽƚďĞƵƐĞĚĨŽƌďůŽŽĚĐŽůůĞĐƟŽŶ͘
- ƌĂǁǁŚŽůĞďůŽŽĚƐĂŵƉůĞŝŶƚŽϭϬŵ>^ƚƌĞĐŬĞůůͲ&ƌĞĞEdƚƵďĞ;ΎƐĞĞŶŽƚĞƌĞŐĂƌĚŝŶŐƉƌĞǀĞŶƟŽŶŽĨďĂĐŬŇŽǁͿ͘&ŝůůƚƵďĞ
ƵŶƟůďůŽŽĚŇŽǁƐƚŽƉƐ͘
- EKd͗ƉŝĐƌĞƋƵŝƌĞƐĂŵŝŶŝŵƵŵŽĨϰŵ>ďůŽŽĚƉĞƌƐĂŵƉůĞ͕ďƵƚĂĨƵůůϭϬŵ>ƚƵďĞŽĨďůŽŽĚƐŚŽƵůĚďĞƉƌŽǀŝĚĞĚǁŚĞŶƉŽƐƐŝďůĞ͘
- ZĞŵŽǀĞ ƚƵďĞ ĨƌŽŵ ĂĚĂƉƚĞƌ ĂŶĚ ŝŵŵĞĚŝĂƚĞůǇ ŵŝǆ ďǇ ŐĞŶƚůĞ ŝŶǀĞƌƐŝŽŶ ϴ ƚŽ ϭϬ ƟŵĞƐ͘ dƵďĞ ŝŶǀĞƌƐŝŽŶ ƉƌĞǀĞŶƚƐ ĐůŽƫŶŐ͘
/ŶĂĚĞƋƵĂƚĞŽƌĚĞůĂǇĞĚŵŝǆŝŶŐŵĂǇƌĞƐƵůƚŝŶŝŶĂĐĐƵƌĂƚĞƚĞƐƚƌĞƐƵůƚƐ͘
- >ĂďĞůƚŚĞƚƵďĞǁŝƚŚƐƵďũĞĐƚ͛ƐŝĚĞŶƟĮĐĂƟŽŶĂŶĚĚĂƚĞĂŶĚƟŵĞŽĨďůŽŽĚĚƌĂǁ͘hŶůĂďĞůĞĚďůŽŽĚƚƵďĞƐŵĂǇŶŽƚďĞƉƌŽĐĞƐƐĞĚ͘
- <ĞĞƉƐĂŵƉůĞĂƚƌŽŽŵƚĞŵƉĞƌĂƚƵƌĞĂŶĚƐŚŝƉŽŶĚĂǇŽĨĐŽůůĞĐƟŽŶŝŶƐŚŝƉƉĞƌĂƚĂŵďŝĞŶƚƚĞŵƉĞƌĂƚƵƌĞ͘
^ƚŽƌĞĂŵďŝĞŶƚƵŶƟůƐŚŝƉŵĞŶƚ͘
^ŚŝƉƚŽƉŝĐ^ĐŝĞŶĐĞƐŽŶƚŚĞĚĂǇŽĨĐŽůůĞĐƟŽŶ͘
Email: partners@epicsciences.com
t,K>>KK

dEWZK^^/E'^>/E͕ ^ĐƌĞĞŶŝŶŐ͕ AMBIENT
^DϬϮͬdE^>/E Cycle 1 Day 1 DAY OF COLLECTION
Cycle 1 Day 12,

Cycle 2 Day 1,
Cycle 3 Day 1,
dEWZK^^/E'EKEͲ^>/E͕
^DϬϯͬdEEKEͲ^>/E
ǀĞƌǇϭϲtĞĞŬƐĨƌŽŵϭϭ͕ 2 x 10.0 mL Streck Cell-Free DNA tubes,
2 x bubble bags
ϭ͘ ŽůůĞĐƚƐƉĞĐŝŵĞŶďǇǀĞŶŝƉƵŶĐƚƵƌĞĂĐĐŽƌĚŝŶŐƚŽ>^/'WϰϭͲϲ͕ůŽĐĂůŐƵŝĚĞůŝŶĞƐ͕ŽƌůĂďŽƌĂƚŽƌǇŵĂŶƵĂů͘
WƌĞǀĞŶƟŽŶŽĨĂĐŬŇŽǁͲ^ŝŶĐĞĞůůͲ&ƌĞĞEdĐŽŶƚĂŝŶƐĐŚĞŵŝĐĂůĂĚĚŝƟǀĞƐ͕ŝƚŝƐŝŵƉŽƌƚĂŶƚƚŽĂǀŽŝĚƉŽƐƐŝďůĞďĂĐŬŇŽǁĨƌŽŵ
ƚŚĞƚƵďĞ͘
dŽŐƵĂƌĚĂŐĂŝŶƐƚďĂĐŬŇŽǁ͕ŽďƐĞƌǀĞƚŚĞĨŽůůŽǁŝŶŐƉƌĞĐĂƵƟŽŶƐ͗
Ă͘ <ĞĞƉƉĂƟĞŶƚ͛ƐĂƌŵŝŶƚŚĞĚŽǁŶǁĂƌĚƉŽƐŝƟŽŶĚƵƌŝŶŐƚŚĞĐŽůůĞĐƟŽŶƉƌŽĐĞĚƵƌĞ͘
ď͘ ,ŽůĚƚŚĞƚƵďĞǁŝƚŚƚŚĞƐƚŽƉƉĞƌŝŶƚŚĞƵƉƉĞƌŵŽƐƚƉŽƐŝƟŽŶƐŽƚŚĂƚƚŚĞƚƵďĞĐŽŶƚĞŶƚƐĚŽŶŽƚƚŽƵĐŚƚŚĞƐƚŽƉƉĞƌŽƌƚŚĞĞŶĚ
ŽĨƚŚĞŶĞĞĚůĞĚƵƌŝŶŐƐĂŵƉůĞĐŽůůĞĐƟŽŶ͘
Đ͘ ZĞůĞĂƐĞƚŽƵƌŶŝƋƵĞƚŽŶĐĞďůŽŽĚƐƚĂƌƚƐƚŽŇŽǁŝŶƚŚĞƚƵďĞ͕ŽƌǁŝƚŚŝŶϮŵŝŶƵƚĞƐŽĨĂƉƉůŝĐĂƟŽŶ͘
Ϯ͘ &ŽůůŽǁƌĞĐŽŵŵĞŶĚĂƟŽŶƐĨŽƌŽƌĚĞƌŽĨĚƌĂǁ͘
ĞůůͲ&ƌĞĞEdƐŚŽƵůĚďĞĚƌĂǁŶĂŌĞƌƚŚĞdƚƵďĞĂŶĚďĞĨŽƌĞƚŚĞŇƵŽƌŝĚĞŽǆĂůĂƚĞ;ŐůǇĐŽůǇƟĐŝŶŚŝďŝƚŽƌͿƚƵďĞ͘
/ĨĂĞůůͲ&ƌĞĞEdƚƵďĞŝŵŵĞĚŝĂƚĞůǇĨŽůůŽǁƐĂŚĞƉĂƌŝŶƚƵďĞŝŶƚŚĞĚƌĂǁŽƌĚĞƌ͕^ƚƌĞĐŬƌĞĐŽŵŵĞŶĚƐĐŽůůĞĐƟŶŐĂŶŽŶͲ
ĂĚĚŝƟǀĞŽƌdƚƵďĞĂƐĂǁĂƐƚĞƚƵďĞƉƌŝŽƌƚŽĐŽůůĞĐƟŽŶŝŶƚŚĞĞůůͲ&ƌĞĞEd͘
ϯ͘ ϯ͘&ŝůůƚŚĞƚƵďĞĐŽŵƉůĞƚĞůǇ͘^ƚƌĞĐŬĞůůͲ&ƌĞĞEdƚƵďĞƐŚĂǀĞĂůŽǁĞƌǀĂĐƵƵŵƚŚĂŶƐŽŵĞŽƚŚĞƌƚƵďĞƚǇƉĞƐĂŶĚƚŚƵƐŵĂǇƚĂŬĞ
ůŽŶŐĞƌƚŽĮůů͘ŽŵƉůĞƚĞĮůůŝŶŐŽĨƚŚĞƚƵďĞŝƐŝŵƉŽƌƚĂŶƚƚŽĞŶƐƵƌĞĐŽƌƌĞĐƚďůŽŽĚƚŽĂĚĚŝƟǀĞƌĂƟŽ͘
ϰ͘ ϰ͘ZĞŵŽǀĞƚƵďĞĨƌŽŵĂĚĂƉƚĞƌ͕ŚŽůĚƚŚĞƚƵďĞĂŶĚŝŵŵĞĚŝĂƚĞůǇŵŝǆďǇŐĞŶƚůĞŝŶǀĞƌƐŝŽŶϭϬƟŵĞƐ͘/ŶĂĚĞƋƵĂƚĞŽƌĚĞůĂǇĞĚŵŝǆŝŶŐ
ŵĂǇƌĞƐƵůƚŝŶŝŶĂĐĐƵƌĂƚĞƚĞƐƚƌĞƐƵůƚƐ͘KŶĞŝŶǀĞƌƐŝŽŶŝƐĂĐŽŵƉůĞƚĞƚƵƌŶŽĨƚŚĞǁƌŝƐƚ͕ϭϴϬĚĞŐƌĞĞƐ͕ĂŶĚďĂĐŬ͘
^ƚŽƌĞĂƚŵďŝĞŶƚƚĞŵƉͲŽEKdĨƌĞĞǌĞƚŚĞďůŽŽĚƐĂŵƉůĞŽƌƐƚŽƌĞďĞůŽǁϲΣ͘
^ŚŝƉƐĂŵƉůĞŝŶƐƵƉƉůŝĞĚƉĂĐŬĂŐŝŶŐĂƚĂŵďŝĞŶƚƚĞŵƉƚŽ>ĂďŽƌƉ;ĞŶƚƌĂů>ĂďͿĂƐƐŽŽŶĂƐƉŽƐƐŝďůĞ;ƐĂŵĞĚĂǇŽƌĨŽůůŽǁŝŶŐĚĂǇͿ͘
BIOPSY/ TUMOR BIOPSY BLOCK

AMBIENT
DAY OF COLLECTION
^DϭϮͬ^/E'>/KW^z>K<͕
KƉƟŽŶĂůdƵŵŽƵƌŝŽƉƐǇ
^DϭϰͬW/Z/KW^z>K<
TO: LABCORP CLS
ϮǆϲϬŵ>ǇĞůůŽǁĐĂƉƐƉĞĐŝŵĞŶĐŽŶƚĂŝŶĞƌƐ͕
ϮǆĐĂƐƐĞƩĞƐ
FROZEN
^Dϭϯͬ^/E'>/KW^zÊW͕ ͳϳϬȗKZ>^^
KƉƟŽŶĂůdƵŵŽƵƌŝŽƉƐǇ MONTHLY
^DϭϱͬW/Z/KW^zÊW
2 x cryovials
TO: LABCORP CLS
dŚĞƚƵŵŽƌďŝŽƉƐǇƉƌŽĐĞĚƵƌĞǁŝůůďĞƉĞƌĨŽƌŵĞĚďǇĐŽƌĞŶĞĞĚůĞ͕ƵŶĚĞƌƌĂĚŝŽůŽŐŝĐĂůŐƵŝĚĂŶĐĞ͕ŽƌƐƵƌŐŝĐĂůůǇŝĨƚŚĞƐŝƚĞŽĨĚŝƐĞĂƐĞŝƐ
ƐƵƉĞƌĮĐŝĂůĂŶĚƉĂůƉĂďůĞŽƌǀŝƐŝďůĞ͘/ƚŝƐŵĂŶĚĂƚĞĚƚŚĂƚƚŚĞĐŽƌĞďŝŽƉƐǇďĞƌĞŵŽǀĞĚĚŝƌĞĐƚůǇĨƌŽŵƚŚĞƚƵŵŽƌŝŶƐŝƚƵĂŶĚŶŽƚĐŽƌĞĚĨƌŽŵ
ĂƐƵƌŐŝĐĂůůǇƌĞŵŽǀĞĚƚƵŵŽƌ͘dŚŝƐŝƐƚŽĞŶƐƵƌĞƚŚĞďĞƐƚƉŽƐƐŝďůĞƋƵĂůŝƚǇŽĨƚŚĞďŝŽƉƐǇ͕ƐŽƚŚĞďůŽŽĚͬŶƵƚƌŝĞŶƚƐƵƉƉůǇƚŽƚŚĞƚƵŵŽƌŝƐŶŽƚ
ĚŝƐƌƵƉƚĞĚƉƌŝŽƌƚŽďŝŽƉƐǇĐŽůůĞĐƟŽŶ͘ŽůůĞĐƟŽŶŽĨƚƵŵŽƌĐĞůůƐĨƌŽŵŇƵŝĚƐƵĐŚĂƐĂƐĐŝƚĞƐŽƌƉůĞƵƌĂůĞīƵƐŝŽŶŝƐŶŽƚƉĞƌŵŝƩĞĚ͘
Cores 1,2 3 to be processed as FFPE:^DϭϮͬ^/E'>/KW^z>K<ͬ^DϭϰͬW/Z/KW^z>K<͘
ŽůůĞĐƚďŝŽƉƐǇƐĂŵƉůĞƐƉƌĞĨĞƌĂďůǇǁŝƚŚĂϭϰŽƌϭϲͲŐĂƵŐĞĐŽƌĞŶĞĞĚůĞ;ƚŚĞŐĂƵŐĞŵĂǇǀĂƌǇĚĞƉĞŶĚĞŶƚŽŶĐĂŶĐĞƌƚǇƉĞĂŶĚĂĐĐĞƐƐƚŽ
ďŝŽƉƐǇͿ͘/ĨƉŽƐƐŝďůĞĂŶĚĐůŝŶŝĐĂůůǇƐĂĨĞƚŽĚŽƐŽ͕ĐŽůůĞĐƚŵƵůƟƉůĞďŝŽƉƐŝĞƐƚŽĞŶƐƵƌĞƐƵĸĐŝĞŶƚƚƵŵŽƌŵĂƚĞƌŝĂůĨŽƌĂŶĂůǇƐŝƐ͕ĂŶĚƉƌŽĐĞƐƐ
ƚŽŐĞƚŚĞƌŝŶŽŶĞďůŽĐŬ͘WůĂĐĞƚŚĞƐƉĞĐŝŵĞŶƐŝŶƚŽƚŚĞĐĞůůƐĂĨĞďŝŽƉƐǇĐĂƉƐƵůĞĂŶĚŝŵŵĞƌƐĞŝŵŵĞĚŝĂƚĞůǇŝŶƚŽϭϬйŶĞƵƚƌĂůďƵīĞƌĞĚ
ĨŽƌŵĂůŝŶƉŽƚĨŽƌĮǆĂƟŽŶ͘>ĞĂǀĞƐĂŵƉůĞ;ƐͿĨŽƌĞǆĂĐƚůǇϮϰŚŽƵƌƐŝŶĨŽƌŵĂůŝŶĂƚƌŽŽŵƚĞŵƉĞƌĂƚƵƌĞ͕ƚŽĂůůŽǁĨŽƌĂĚĞƋƵĂƚĞĮǆĂƟŽŶŽĨƚŚĞ
ƐĂŵƉůĞƐ͘ZĞŵŽǀĞƚŚĞĐĞůůƐĂĨĞďŝŽƉƐǇĐĂƉƐƵůĞ;ĐŽŶƚĂŝŶŝŶŐƚŚĞďŝŽƉƐǇͿĨƌŽŵƚŚĞĨŽƌŵĂůŝŶ͘WůĂĐĞƚŚĞĮǆĞĚďŝŽƉƐǇƐĂŵƉůĞ;ƐͿŝŶƐŝĚĞƚŚĞ
ďůŽĐŬĐĂƐƐĞƩĞĂŶĚŝŵŵĞĚŝĂƚĞůǇƉƌŽĐĞƐƐƚŽƉĂƌĂĸŶƵƐŝŶŐƚŚĞƉƌĞĨĞƌƌĞĚZŽƵƟŶĞŝŽƉƐǇWĂƌĂĸŶWƌŽĐĞƐƐŝŶŐƐĐŚĞĚƵůĞ͘
;EŽƚĞ͕ ŝĨ ŵƵůƟƉůĞ ĐŽƌĞ ďŝŽƉƐŝĞƐ ĂƌĞ ĐŽůůĞĐƚĞĚ ƚŚĞŶ ƚŚĞǇ ƐŚŽƵůĚ ďĞ ƉůĂĐĞĚ ŝŶƚŽ ƚŚĞ ƐĂŵĞ ĐĂƐƐĞƩĞ ďůŽĐŬ ĂŶĚ ƉƌŽĐĞƐƐĞĚ ƚŽŐĞƚŚĞƌͿ͘
/ŵƉŽƌƚĂŶƚ͗dŚĞŝƐĐŚĞŵŝĂƟŵĞ;ĨƌŽŵƌĞŵŽǀĂůŽĨƐĂŵƉůĞƚŽĨŽƌŵĂůŝŶŝŵŵĞƌƐŝŽŶͿŶĞĞĚƐƚŽďĞŵŝŶŝŵŝǌĞĚƚŽŽƉƟŵĂůůǇƉƌĞƐĞƌǀĞƚƵŵŽƌ
ƐĂŵƉůĞƐĨŽƌďŝŽŵĂƌŬĞƌŝŶǀĞƐƟŐĂƟŽŶ͘dŚĞĮǆĂƟŽŶƉĞƌŝŽĚďĞƚǁĞĞŶƐĂŵƉůĞĐŽůůĞĐƟŽŶĂŶĚƉĂƌĂĸŶĞŵďĞĚĚŝŶŐǁŝůůďĞϮϰŚŽƵƌƐ͘
^ŚŝƉƐĂŵƉůĞƐŝŶϲϬŵ>ǇĞůůŽǁĐƵƉĐŽŶƚĂŝŶĞƌĂŵďŝĞŶƚƚŽ>ĂďŽƌƉ>^ĚĂǇŽĨĐŽůůĞĐƟŽŶ͘
Core 4 to be Snap Frozen:^Dϭϯͬ^/E'>/KW^zÊW͕^DϭϱͬW/Z/KW^zÊW͘
ŽůůĞĐƚďŝŽƉƐǇƐĂŵƉůĞƐƉƌĞĨĞƌĂďůǇǁŝƚŚĂϭϰŽƌϭϲͲŐĂƵŐĞĐŽƌĞŶĞĞĚůĞ;ƚŚĞŐĂƵŐĞŵĂǇǀĂƌǇĚĞƉĞŶĚĞŶƚŽŶĐĂŶĐĞƌƚǇƉĞĂŶĚĂĐĐĞƐƐƚŽ
ďŝŽƉƐǇͿ͘
ŽƌĞďŝŽƉƐǇϰƐŚŽƵůĚďĞƉůĂĐĞĚŝŵŵĞĚŝĂƚĞůǇŝŶϮŵ>ĐƌǇŽǀŝĂůƚƵďĞƐĂŶĚƐŶĂƉĨƌŽǌĞŶǁŝƚŚŝŶϭŵŝŶƵƚĞŽĨĐŽůůĞĐƟŽŶƵƐŝŶŐƚŚĞƐŝƚĞ͛ƐƐŶĂƉ
ĨƌĞĞǌŝŶŐƉƌŽĐĞĚƵƌĞ;ůŝƋƵŝĚŶŝƚƌŽŐĞŶŝƐƉƌĞĨĞƌƌĞĚͿ͘
&ƌŽǌĞŶďŝŽƉƐŝĞƐƐŚŽƵůĚďĞƐƚŽƌĞĚĂƚͲϳϬȗŽƌůĞƐƐĂƚĂůůƟŵĞƐĂŶĚƐŚŝƉƉĞĚŽŶĚƌǇŝĐĞŵŽŶƚŚůǇƚŽ>ĂďŽƌƉ>^͘
FFPE BLOCK

AMBIENT
^DϬϰͬZ,ͬEt&&W,Θ^>/ DĂŶĚĂƚŽƌǇ&&WůŽĐŬ DAY OF COLLECTION
^DϬϵͬZ,ͬEt&&W>K< DĂŶĚĂƚŽƌǇ&&WůŽĐŬ TO: LABCORP CLS
ϭǆϲϬŵ>ǇĞůůŽǁĐĂƉƐƉĞĐŝŵĞŶĐŽŶƚĂŝŶĞƌ͕
ϭǆƐůŝĚĞŵĂŝůĞƌ͕ϮǆůĂďĞůƐǁŝƚŚWĂƌ
dŚĞŵŽƐƚƌĞĐĞŶƚůǇĐŽůůĞĐƚĞĚƚƵŵŽƌƟƐƐƵĞ͕ĨƌŽŵƉƌŝŵĂƌǇŽƌƌĞĐƵƌƌĞŶƚĐĂŶĐĞƌŝƐƌĞƋƵŝƌĞĚ͘
&ŽƌŵĂůŝŶĮǆĞĚƉĂƌĂĸŶĞŵďĞĚĚĞĚƟƐƐƵĞ;&&WͿďůŽĐŬƐĂƌĞƐƚƌŽŶŐůǇƉƌĞĨĞƌƌĞĚ͘
dƵŵŽƌďůŽĐŬƐĂŶĚƐůŝĚĞƐŵĞĞƟŶŐĂŶǇŽĨƚŚĞĐƌŝƚĞƌŝĂďĞůŽǁĂƌĞŶŽƚĂĐĐĞƉƚĞĚ͗
• ǇƚŽůŽŐǇƐĂŵƉůĞƐĂŶĚĮŶĞŶĞĞĚůĞĂƐƉŝƌĂƚĞƐ͘
• ĞůůƵůĂƌĂƐƉŝƌĂƚĞƐ͕ǁŚŝĐŚĐŽŵƉƌŝƐĞůŽŽƐĞĐĞůůƵůĂƌĐŽŶƚĞŶƚǁŝƚŚŶŽŝŶƚĞŐƌŝƚǇĂŶĚƐƚƌƵĐƚƵƌĂůŵŽƌƉŚŽůŽŐǇ͕ĂƌĞŶŽƚĂĐĐĞƉƚĂďůĞ͘
• ^ĂŵƉůĞƐƚŚĂƚŚĂǀĞƵŶĚĞƌŐŽŶĞĚĞĐĂůĐŝĮĐĂƟŽŶ;ŝ͘Ğ͘ƚƌĞĂƚŵĞŶƚǁŝƚŚŵŝŶĞƌĂůĂĐŝĚƐŽƌŽƌŐĂŶŝĐĂĐŝĚƐͿ͘
ŽůůĞĐƟŽŶŵĞƚŚŽĚ͗
• WƌŽǀŝĚĞƚŚĞŵŽƐƚƌĞĐĞŶƚůǇĐŽůůĞĐƚĞĚƚƵŵŽƌƐĂŵƉůĞ͘
• &&WƐƉĞĐŝŵĞŶƐ͕ŝŶĐůƵĚŝŶŐƚƵŵŽƌƌĞƐĞĐƟŽŶƐĂŶĚĐŽƌĞŶĞĞĚůĞďŝŽƉƐŝĞƐĂƌĞĂĐĐĞƉƚĂďůĞ͘
• DƵůƟƉůĞĐŽƌĞƐĞŵďĞĚĚĞĚŝŶĂƐŝŶŐůĞďůŽĐŬĂƌĞƉƌĞĨĞƌƌĞĚĨŽƌďŝŽƉƐŝĞƐ͘
^ĂŵƉůĞƉƌĞƉĂƌĂƟŽŶĂŶĚĮǆĂƟŽŶ͘
• ϭϬйŶĞƵƚƌĂůͲďƵīĞƌĞĚĨŽƌŵĂůŝŶĨŽƌϲͲϳϮŚŽƵƌƐŝƐŝŶĚƵƐƚƌǇƐƚĂŶĚĂƌĚ͘
Note: ǌŝŶĐďƵīĞƌĞĚĨŽƌŵĂůŝŶŶŽƚĂĐĐĞƉƚĂďůĞ͘ ŽŶŽƚƵƐĞŽƚŚĞƌĮǆĂƟǀĞƐ;ŽƵŝŶƐ͕ϱ͕,ŽůůĂŶĚ͛Ɛ͕ĞƚĐ͘Ϳ͘
• ŽŶŽƚ͚ďĂŬĞ͛ƚŚĞƐůŝĚĞƐĚƵƌŝŶŐƉƌĞƉĂƌĂƟŽŶ͕ƚŚŝƐůĞĂĚƐƚŽƐƵďͲŽƉƟŵĂůƟƐƐƵĞƌĞĐŽǀĞƌǇĨŽƌEĞǆƚƌĂĐƟŽŶ͘
• ǀŽŝĚƐĂŵƉůĞĐŽŶƚĂŵŝŶĂƟŽŶǁŚĞƌĞƉŽƐƐŝďůĞ͘
ĞƐƚWƌĂĐƟĐĞƐĨŽƌWƌĞǀĞŶƟŶŐƌŽƐƐͲŽŶƚĂŵŝŶĂƟŽŶďĞƚǁĞĞŶ^ĂŵƉůĞƐ͘
ƵƌŝŶŐƚƵŵŽƵƌƟƐƐƵĞƐĞĐƟŽŶŝŶŐƚŚĞŵŝĐƌŽƚŽŵĞŵƵƐƚďĞĐůĞĂŶĞĚǁŝƚŚĂƐŽůǀĞŶƚďĂƐĞĚĐůĞĂŶĞƌƐƵĐŚĂƐ͞WĂƌĂŐƵĂƌĚ͕͟ƚŽƌĞŵŽǀĞ
ƟƐƐƵĞŝŶƉĂƌĂĸŶĨƌŽŵƚŚĞŵŝĐƌŽƚŽŵĞďůĂĚĞĂŶĚĂƌŽƵŶĚƚŚĞŵŝĐƌŽƚŽŵĞ͗
- ůĞĂŶĨƌŽŶƚΘďĞŚŝŶĚƚŚĞŬŶŝĨĞŚŽůĚĞƌďĂƐĞĂŶĚƚŚĞƐĞĐƟŽŶĐŽůůĞĐƟŽŶƚƌĂǇ͘
- ϳϬйĞƚŚĂŶŽůƐŽůƵƟŽŶĐĂŶďĞƵƐĞĚƚŽĐůĞĂŶƐƵƌĨĂĐĞƐ͘
- DŝĐƌŽƚŽŵĞďůĂĚĞŵƵƐƚďĞĐŚĂŶŐĞĚďĞƚǁĞĞŶƚƵŵŽƵƌƐĂŵƉůĞƐ͘
- dŽŽůƐŵƵƐƚďĞĐůĞĂŶĞĚďĞƚǁĞĞŶƐĂŵƉůĞƐ͘
- ůůƐŚĂǀŝŶŐƐŵƵƐƚďĞƌĞŵŽǀĞĚĂŶĚĐůĞĂŶĞĚĨƌŽŵƚŚĞŵŝĐƌŽƚŽŵĞďĞƚǁĞĞŶƐĂŵƉůĞƐ͘
- ŝƐƉŽƐĂďůĞƉůĂƐƟĐǁĂƌĞƐŚŽƵůĚďĞƵƐĞĚƚŽƚƌĂŶƐĨĞƌƐĞĐƟŽŶƐƚŽŐůĂƐƐƐůŝĚĞƐ͘
- dŚĞƵƐĞŽĨǁĂƚĞƌďĂƚŚƐƚŽƐƚƌĞƚĐŚƐĞĐƟŽŶƐĐĂŶďĞĂǀŽŝĚĞĚďǇƵƐŝŶŐĂĚƌŽƉůĞƚŽĨWZƋƵĂůŝƚǇǁĂƚĞƌŽŶŐůĂƐƐƐůŝĚĞƐ͘
- ĂƌĞƐŚŽƵůĚďĞƚĂŬĞŶƚŚĂƚĚĞĐŽŶƚĂŵŝŶĂƟŽŶƉƌŽĐĞĚƵƌĞƐĚŽŶŽƚƌĞĚƵĐĞEŽƌZEůĞǀĞůƐƌĞƋƵŝƌĞĚĨŽƌĚŽǁŶƐƚƌĞĂŵƉƌŽĐĞƐƐŝŶŐ
ǁŚĞŶĐƵƫŶŐƐĞĐƟŽŶƐ͘
͘Ő͘ƵƐĞŽĨEǌĂƉǁŝƉĞƐŽŶŵŝĐƌŽƚŽŵĞďůĂĚĞƐŝŵŵĞĚŝĂƚĞůǇďĞĨŽƌĞĐƵƫŶŐƐĞĐƟŽŶƐĐĂŶƌĞĚƵĐĞEůĞǀĞůƐƐƵďƐƚĂŶƟĂůůǇĂŶĚƐŚŽƵůĚ
ďĞĂǀŽŝĚĞĚ͘
dŚĞƵƐĞŽĨƐƵďƐƚĂŶĐĞƐůŝŬĞůǇƚŽŝŶŚŝďŝƚWZƐŚŽƵůĚĂůƐŽďĞĂǀŽŝĚĞĚ͘
Minimum sample size:
• &Žƌ&&WďůŽĐŬ͗ƉƌŽǀŝĚĞĂďůŽĐŬƚŽƚĂůŝŶŐŵŝŶŝŵƵŵϭϬϬʅŵŽĨ&&WƟƐƐƵĞ͘
DŝŶŝŵƵŵƚƵŵŽƌĂƩƌŝďƵƚĞƐ͗
• шϯϬйƚƵŵŽƌŶƵĐůĞŝƉƌĞĨĞƌƌĞĚ͘
• шϮϬйƚƵŵŽƌŶƵĐůĞŝŝƐĂĐĐĞƉƚĂďůĞ͘
• &&WƚƵŵŽƌďůŽĐŬнϭŽƌŝŐŝŶĂů;ŶŽƚƌĞĐƵƚͿ,ΘƐůŝĚĞŝĨĂǀĂŝůĂďůĞ͘
• ^ŝƚĞƐƐŚŽƵůĚƐĞůĞĐƚƚŚĞŽƉƟŵƵŵďůŽĐŬ;ƚŚĞůĂƌŐĞƐƚƟƐƐƵĞƐĂŵƉůĞǁŝƚŚƚŚĞŚŝŐŚĞƐƚƚƵŵŽƌĐŽŶƚĞŶƚʹŝĨƵŶƐƵƌĞŵƵůƟƉůĞďůŽĐŬƐ
ĐĂŶďĞƐĞŶƚƉĞƌƉĂƟĞŶƚ;DĂǆŝŵƵŵϯďůŽĐŬƐŽŶůǇнŽŶĞĐŽŵƉůĞƚĞĚƌĞƋƵŝƐŝƟŽŶĨŽƌŵƉĞƌďůŽĐŬͿ͘
• DĂǆŝŵƵŵƐŝǌĞŽĨďůŽĐŬ͗ϮϱǆϮϱŵŵ͘
• WůĂĐĞ&&WďůŽĐŬŝŶƐŝĚĞƵŶůĂďĞůĞĚϲϬŵ>ǇĞůůŽǁĐƵƉĐŽŶƚĂŝŶĞƌƉƌŽǀŝĚĞĚǁŝƚŚŝŶƚŚĞŬŝƚ͘
• WůĂĐĞƚŚĞ,ΘƐůŝĚĞ͕ŝĨĂǀĂŝůĂďůĞ͕ŝŶƚŚĞϭƐůŝĚĞƐůŽƚƐůŝĚĞŵĂŝůĞƌ͘
• ^ƟĐŬƚŚĞůĂďĞůŽŶƚŚĞϲϬŵ>ǇĞůůŽǁĐƵƉĐŽŶƚĂŝŶĞƌĂŶĚ͕ŝĨŶĞĞĚĞĚ͕ŽŶƚŚĞϭƐůŝĚĞƐůŽƚƐůŝĚĞŵĂŝůĞƌ͘EŽƚĞ͗ĞŶƐƵƌĞƚŚĂƚĂĐŽƌƌĞĐƚ
ůĂďĞůŝƐƉůĂĐĞĚŽŶƚŚĞĐŽŶƚĂŝŶĞƌ͊
• dƵŵŽƌ ďůŽĐŬƐ ƐŚŽƵůĚ ďĞ ƐƚŽƌĞĚ Ăƚ ĂŵďŝĞŶƚ ƚĞŵƉĞƌĂƚƵƌĞ ĂŶĚ ƉƌŽƚĞĐƚĞĚ ĨƌŽŵ ůŝŐŚƚ ƵŶƟů ƐŚŝƉŵĞŶƚ ďǇ ĐŽƵƌŝĞƌ Ăƚ ĂŵďŝĞŶƚ
ƚĞŵƉĞƌĂƚƵƌĞĚĂǇŽĨĐŽůůĞĐƟŽŶ͘
^ŚŝƉƚŚĞƐĂŵƉůĞĂŵďŝĞŶƚǁŝƚŚƚŚĞĐŽŵƉůĞƚĞĚƌĞƋƵŝƐŝƟŽŶĨŽƌŵĂŶĚƚŚĞƉĂƚŚŽůŽŐǇƌĞƉŽƌƚƚŽ>ĂďŽƌƉĚĂǇŽĨĐŽůůĞĐƟŽŶ͘
PATHOLOGY REPORT

AMBIENT
DAY OF COLLECTION
DĂŶĚĂƚŽƌǇ&&WůŽĐŬ͕
^DϭϭͬWd,K>K'zZWKZd DĂŶĚĂƚŽƌǇ&&W^ůŝĚĞƐϭͲϱ;/,Ϳ͕
DĂŶĚĂƚŽƌǇ&&W^ůŝĚĞƐϲͲϯϬ;E'^Ϳ TO: LABCORP CLS
1 x envelope, 1 x label
ϭ͘ ĐŽƌƌĞƐƉŽŶĚŝŶŐƉĂƚŚŽůŽŐǇƌĞƉŽƌƚƐŚŽƵůĚďĞƐĞŶƚǁŝƚŚďůŽĐŬŽƌƐůŝĚĞƐ͘
Ϯ͘ ŽŶĮƌŵƚŚĞƉĂƟĞŶƚ͛ƐŶĂŵĞĂŶĚĂůůƉĞƌƐŽŶĂůŝĚĞŶƟĮĞƌƐ;K͕ĚĚƌĞƐƐ͕^Ğǆ͕ĞƚĐ͙ͿĂƌĞŶŽƚƌĞĐŽƌĚĞĚƚŽĞŶƐƵƌĞĐŽŶĮĚĞŶƟĂůŝƚǇ
;ďůĂĐŬŽƵƚƉĂƟĞŶƚŶĂŵĞŽŶWĂƚŚŽůŽŐǇZĞƉŽƌƚͿ͘
ϯ͘ ƐĂƉƉůŝĐĂďůĞ͕ƉůĞĂƐĞƌĞƚĂŝŶĂŶǇŝŶƐƟƚƵƟŽŶĂůĐŽĚĞƐůŝŶŬŝŶŐƚŚĞƉĂƚŚŽůŽŐǇƌĞƉŽƌƚƚŽƚŚĞĐŽƌƌĞƐƉŽŶĚŝŶŐďůŽĐŬŽƌƐůŝĚĞƐ͘
ϰ͘ /ŶĐůƵĚĞƚŚĞĚĞͲŝĚĞŶƟĮĞĚƉĂƚŚŽůŽŐǇƌĞƉŽƌƚŝŶƚŚĞĞŶǀĞůŽƉĞƉƌŽǀŝĚĞĚ͘dŚŝƐŝƐƚŽŵĂŝŶƚĂŝŶƐƉĞĐŝŵĞŶŝĚĞŶƟĮĐĂƟŽŶĨŽƌƉƌŽĐĞƐƐŝŶŐ͘
ϱ͘ ^ŚŝƉƚŚĞƉĂƚŚŽůŽŐǇƌĞƉŽƌƚĂŵďŝĞŶƚǁŝƚŚŝŶƚŚĞĞŶǀĞůŽƉĞƉƌŽǀŝĚĞĚƚŽŐĞƚŚĞƌǁŝƚŚƚŚĞďůŽĐŬͬƐůŝĚĞƐƚŽ>ĂďŽƌƉ>^͘
PAXGENE RNA

^ĐƌĞĞŶŝŶŐ͕ FROZEN
Cycle 1 Day 1, ͳϮϬΣ
MONTHLY
Cycle 1 Day 12,
Cycle 2 Day 1,
^DϬϳͬt,K>>KKZE
Cycle 3 Day 1,
1 x 2.5 mL PAXgene™ blood RNA tube, 1 x bubble bag
ŝƐĐŽŶƟŶƵĂƟŽŶ
ϭ͘ ŶƐƵƌĞƚŚĂƚƚŚĞWyŐĞŶĞƚƵďĞƐĂƌĞƐƚŽƌĞĚĂƚƌŽŽŵƚĞŵƉĞƌĂƚƵƌĞ͘
Ϯ͘ ƌĂǁƚŚĞWyŐĞŶĞƚƵďĞƐůĂƐƚ͘
ϯ͘ WƌĞǀĞŶƚĂĐŬŇŽǁ͘,ŽůĚƚŚĞWyŐĞŶĞůŽŽĚZEdƵďĞǀĞƌƟĐĂůůǇ͕ďĞůŽǁƚŚĞďůŽŽĚĚŽŶŽƌ͛ƐĂƌŵ͕ĚƵƌŝŶŐďůŽŽĚĐŽůůĞĐƟŽŶ͘ZĞůĞĂƐĞ
ƚŚĞƚŽƵƌŶŝƋƵĞƚĂƐƐŽŽŶĂƐďůŽŽĚƐƚĂƌƚƐƚŽŇŽǁŝŶƚŽƚŚĞƚƵďĞ͘DĂŬĞƐƵƌĞƚƵďĞĂĚĚŝƟǀĞƐĚŽŶŽƚƚŽƵĐŚƐƚŽƉƉĞƌŽƌĞŶĚŽĨŶĞĞĚůĞ
ĚƵƌŝŶŐǀĞŶŝƉƵŶĐƚƵƌĞ͘
CAUTION:WyŐĞŶĞůŽŽĚZEdƵďĞƐĐŽŶƚĂŝŶĂĐŚĞŵŝĐĂůĂĚĚŝƟǀĞĂŶĚŝƚŝƐŝŵƉŽƌƚĂŶƚƚŽĂǀŽŝĚďĂĐŬŇŽǁĨƌŽŵƚŚĞƚƵďĞƚŽĞůŝŵŝŶĂƚĞ
ƉŽƐƐŝďůĞƉĂƟĞŶƚĂĚǀĞƌƐĞƌĞĂĐƟŽŶ͘
ϰ͘ ůůŽǁĂƚůĞĂƐƚϭϬƐĞĐŽŶĚƐĨŽƌĂĐŽŵƉůĞƚĞďůŽŽĚĚƌĂǁƚŽƚĂŬĞƉůĂĐĞ͘ŶƐƵƌĞƚŚĂƚƚŚĞďůŽŽĚŚĂƐƐƚŽƉƉĞĚŇŽǁŝŶŐŝŶƚŽƚŚĞƚƵďĞ
ďĞĨŽƌĞƌĞŵŽǀŝŶŐĂƚƵďĞĨƌŽŵƚŚĞŚŽůĚĞƌ͘
ϱ͘ ŌĞƌĚƌĂǁŝŵŵĞĚŝĂƚĞůǇŵŝǆďǇŐĞŶƚůĞŝŶǀĞƌƐŝŽŶϭϬƟŵĞƐ͘/ŶĂĚĞƋƵĂƚĞŽƌĚĞůĂǇĞĚŵŝǆŝŶŐŵĂǇƌĞƐƵůƚŝŶŝŶĂĐĐƵƌĂƚĞƚĞƐƚƌĞƐƵůƚƐ͘
KŶĞŝŶǀĞƌƐŝŽŶŝƐĂĐŽŵƉůĞƚĞƚƵƌŶŽĨƚŚĞǁƌŝƐƚ͕ϭϴϬĚĞŐƌĞĞƐ͕ĂŶĚďĂĐŬ͘
ϲ͘ ^ƚĂŶĚƚŚĞWyŐĞŶĞůŽŽĚZEdƵďĞ;ƐͿƵƉƌŝŐŚƚŝŶĂǁŝƌĞƌĂĐŬĂƚƌŽŽŵƚĞŵƉĞƌĂƚƵƌĞĨŽƌϮͲϯŚŽƵƌƐ;ƚƵďĞƐŵĂǇďĞůĞŌĂƚĂŵďŝĞŶƚ
ĨŽƌƵƉƚŽϳϮŚŽƵƌƐŵĂǆͿ͘
ϳ͘ dƌĂŶƐĨĞƌƵƉƌŝŐŚƚƚŽĂƐƚĂŶĚĂƌĚĨƌĞĞǌĞƌ;ͲϮϬƚŽͲϯϬΣͿ͘ŽŶŽƚƵƐĞĂ^ƚǇƌŽĨŽĂŵƚƌĂǇĂƐƚŚŝƐŵĂǇĐĂƵƐĞƚƵďĞƐƚŽĐƌĂĐŬ͘
ϴ͘ EŽƚĞ͗ƚŚĞƐĂŵƉůĞƚƵďĞƐĐĂŶďĞƐƚŽƌĞĚĂƚͲϮϬΣ͘/ĨƚƵďĞƐĂƌĞƚŽďĞŬĞƉƚďĞůŽǁͲϮϬΣ͕ĨƌĞĞǌĞƚŚĞŵĮƌƐƚĂƚͲϮϬΣĨŽƌϮϰŚƌƐ͘ƚŚĞŶ
ƚƌĂŶƐĨĞƌƚŽͲϴϬΣ͘
ϵ͘ EŽƚĞ͗WĂǆ'ĞŶĞƚƵďĞƐƐŚŽƵůĚŶŽƚďĞƉůĂĐĞĚĚŝƌĞĐƚůǇŽŶĚƌǇŝĐĞ͕ĚƵƌŝŶŐƚƌĂŶƐƉŽƌƚĞŶƐƵƌĞƚƵďĞƐĂƌĞďƵīĞƌĞĚĨƌŽŵĚŝƌĞĐƚĐŽŶƚĂĐƚ
ǁŝƚŚƚŚĞĚƌǇŝĐĞ͘
ϭϬ͘ tƌĂƉƚƵďĞƐŝŶďƵďďůĞǁƌĂƉͬďĂŐƐĨŽƌƉƌŽƚĞĐƟŽŶĂƐWy'ĞŶĞƚƵďĞƐĂƌĞƉƌŽŶĞƚŽďƌĞĂŬĂŐĞ͘
ϭϭ͘ ^ŚŝƉĨƌŽǌĞŶŽŶĚƌǇŝĐĞƚŽ>ĂďŽƌƉ>^ŵŽŶƚŚůǇ;ŽƌǁŝƚŚŝŶϮǁĞĞŬƐŝĨƐƚŽƌĞĚĂƚͲϮϬΣͿ͘
SLIDES

AMBIENT
DAY OF COLLECTION
^DϭϬͬZ,ͬEt&&W DĂŶĚĂƚŽƌǇ&&W
^>/^ϭͲϱ ^ůŝĚĞƐϭͲϱ;/,Ϳ
TO: LABCORP CLS
ϭǆϮϱƐůŝĚĞƐĞŵƉƚǇƐŽůŝĚƉůĂƐƟĐďŽǆ͕ϭǆŵŝĐƌŽƐĐŽƉĞƐůŝĚĞ͕
ϭǆůĂďĞůǁŝƚŚWĂƌ
EŽƚůĞƐƐƚŚĂŶϱĨƌĞƐŚůǇĐƵƚƵŶƐƚĂŝŶĞĚƐĞƌŝĂůƚƵŵŽƌƟƐƐƵĞƐĞĐƟŽŶƐƐŚŽƵůĚďĞƐƵďŵŝƩĞĚ͘
• dŝƐƐƵĞƐĞĐƟŽŶƐƐŚŽƵůĚďĞŵŽƵŶƚĞĚŽŶƚŽƉŽƐŝƟǀĞůǇĐŚĂƌŐĞĚƐůŝĚĞƐ͘
• &Žƌ&&WƐůŝĚĞƐ͗шϮϱŵŵϮƐƵƌĨĂĐĞĂƌĞĂƉĞƌƐĞĐƟŽŶ͘
WƌĞƉĂƌĞƐĞĐƟŽŶƐϰŵŝĐƌŽŶƐƚŚŝĐŬƵƐŝŶŐƐƵƉĞƌĨƌŽƐƚƉŽƐŝƟǀĞůǇĐŚĂƌŐĞĚƐůŝĚĞƐ
^ŚŝƉƚŚĞƐůŝĚĞƐĂŵďŝĞŶƚǁŝƚŚƚŚĞĐŽŵƉůĞƚĞĚƌĞƋƵŝƐŝƟŽŶĨŽƌŵĂŶĚƚŚĞƉĂƚŚŽůŽŐǇƌĞƉŽƌƚƚŽ>ĂďŽƌƉĚĂǇŽĨĐŽůůĞĐƟŽŶ͘
SLIDES

AMBIENT
DAY OF COLLECTION
^DϭϲͬZ,ͬEt&&W DĂŶĚĂƚŽƌǇ&&W
^>ϲͲϯϬ ^ůŝĚĞƐϲͲϯϬ;E'^Ϳ
TO: LABCORP CLS
ϭǆϮϱƐůŝĚĞƐĞŵƉƚǇƐŽůŝĚƉůĂƐƟĐďŽǆ͕ϭǆŵŝĐƌŽƐĐŽƉĞƐůŝĚĞ͕
ϭǆůĂďĞůǁŝƚŚWĂƌ
Ϯϱ;ŵŝŶŝŵƵŵϮϬͿĨƌĞƐŚůǇĐƵƚƵŶƐƚĂŝŶĞĚƐĞƌŝĂůƚƵŵŽƌƟƐƐƵĞƐĞĐƟŽŶƐƐŚŽƵůĚďĞƐƵďŵŝƩĞĚ͘
• dŝƐƐƵĞƐĞĐƟŽŶƐƐŚŽƵůĚďĞŵŽƵŶƚĞĚŽŶƚŽƉŽƐŝƟǀĞůǇĐŚĂƌŐĞĚƐůŝĚĞƐ͘
• &Žƌ&&WƐůŝĚĞƐ͗шϮϱŵŵϮƐƵƌĨĂĐĞĂƌĞĂƉĞƌƐĞĐƟŽŶƉƌĞĨĞƌƌĞĚ͘
^ŚŝƉƚŚĞƐůŝĚĞƐĂŵďŝĞŶƚǁŝƚŚƚŚĞĐŽŵƉůĞƚĞĚƌĞƋƵŝƐŝƟŽŶĨŽƌŵĂŶĚƚŚĞƉĂƚŚŽůŽŐǇƌĞƉŽƌƚƚŽ>ĂďŽƌƉĚĂǇŽĨĐŽůůĞĐƟŽŶ͘
CENTRIFUGE INSTRUCTIONS
Nomograph for calculating the centrifuge speed:
Radius Speed
SCALE A SCALE B
g
SCALE C
Using the RCF Nomograph

To determine the relative centrifugal
field (RCF), place a straightedge
on the nomograph connecting the
known speed (rpm) and the known
ROTATING RADIUS - CENTIMETERS
rotating radius. The point at which

ROTATING RADIUS - INCHES
the straightedge intersects the RCF B
SPEED - REVOLUTIONS PER MINUTE

axis is the field.
RELATIVE CENTRIFUGAL FORCE - GRAVITIES
For example, if the rotating radius is

10 cm and the speed is 3,000 rpm,
the relative centrifugal field is 1,000 C
• g (gravity)
If the field and the radius are known,
the corresponding speed can be
determined.
To calculate RCF
RCF = 0.00001118 • r • N2
RCF = relative centrifugal
A field (gravities)
r = rotating radius
(centimeters)
N = rotating speed
(revolutions per min)
The distance measured from the rotor axis to the tip of the liquid inside the tubes at the greatest horizontal distance
from the rotor axis is the rotating tip radius. The radius is listed for your convenience in the speed and force tables.
Rotating Axis
ROTATING RADIUS ROTATING RADIUS

ANGLE ROTORS HORIZONTAL ROTORS
English_Centrifuge Instructions_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
Order of Draw
The following provides the recommended order of draw according to the Clinical and Laboratory
Standards Institute (CLSI H3-A6, Vol 27, No 26, 8.10)
Recommended Order of Draw for Tube Collections

Cap Color Collection Tube
Draw First
Blood Cultures
Citrate Tube*
Ѻ# )0.$)"2$)" '***'' /$*). /Ѱ0// -‫ݧ‬4) ' 2$/#/#
attached tubing) for venipuncture and a coagulation (citrate) tube is
/# ‫ݦ‬-.//0 ) я‫ݦ‬-./-2$.-/0 0.$)")*)$/$1
/0 ю# $.-/0 ) )*/ ‫(* ''ݦ‬+' / '4ю
Serum Tube
Heparin Tube
EDTA
Draw Last Fluoride (Glucose) Tube
Note: Always follow your facility’s recommendation or SOP for order of draw should they differ from the
above.
English_DrawOrder_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
SINGLE USE NEEDLE PROTECTION DEVICE INSTRUCTIONS
INSTRUCTIONS FOR USE:
Holding both pink shield and While holding the needle firmly, a) Rotate pink safety shield back
green cap, twist and remove screw holder onto needle until it toward the holder.
white cap. fits securely. b) Twist and pull green needle
cap straight off.
Perform venipuncture according Immediately after removing DO NOT remove needle from
to your facility’s established needle from vein, cover needle holder. Dispose of the needle
procedures. by pushing pink safety shield and holder as one unit into
forward with thumb until an nearest sharps container. DO
audible click is heard. DO NOT NOT REUSE.
attempt to engage shield by
pressing against hard surface.
IMPORTANT SAFETY TIPS

• DO NOT REUSE HOLDER
• Holder threads are designed to be used ONLY ONCE. Reuse of holder is potentially
unsafe and could result in serious injury or exposure to bloodborne pathogens.
• Once holder has been attached to the needle, DO NOT UNWIND it to readjust, or to BD Vacutainer Systems
change needles. Preanalytical Solutions
• Dispose of needle and holder as a single unit. 1 Becton Drive
Franklin Lakes, NJ 07417
BD, BD Logo and Eclipse are trademarks of Becton, Dickinson and Company. ©2002 BD.
English_Venipuncture Needle Protection Device_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
BIOTIN INTERFERENCE
Biotin (Vitamin B7) May Interfere with Lab Tests
Labcorp Central Laboratory Services would like to make Clinicians aware that some assays can be affected by high levels of biotin
in a patient’s serum/plasma. High dose biotin may be prescribed in the treatment of multiple sclerosis or dermatologic conditions.
Thinking it is a contributor to keratin, some people take biotin supplements hoping to improve their hair, skin and nails. Over-the-
counter formulations are available under a variety of names including Vitamin B7, Vitamin H and coenzyme R. These may contain
nearly 1,000 times the Institute of Medicine-recommended daily dose of 30 mcg.
Many laboratory immunoassays utilize the interaction of biotin with streptavidin. Patient samples with high levels of biotin can
interfere with these tests, causing falsely high or falsely low results depending on the assay mechanism. Physicians should be
aware that high levels of biotin supplementation may have an impact over a period of at least 72 hours.
The following are some recommendations for Health Care Providers from the FDA Safety Communication on Biotin:
• Talk to your patients about any biotin supplements they may be taking, including supplements marketed for hair, skin, and
nail growth.
• Be aware that many lab tests, including but not limited to cardiovascular diagnostic tests and hormone tests, that use biotin
/ #)*'*"4- +*/ )/$''4Ȃ / я)$)*-- // ./- .0'/.(4 " ) -/ $!/# - $.$*/$)$)/# +/$ )/њ..+ $( )ю
• If a lab test result doesn’t match the clinical presentation of your patient, consider biotin interference as a possible source of
error.
• Know that biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements
for hair, skin, and nail growth in levels that may interfere with lab tests.
• Report to the lab test manufacturer and the FDA if you become aware of a patient experiencing an adverse event following
potentially incorrect laboratory test results due to biotin interference.
Immunoassy tests with potential interference by Biotin Supplimentation
Note: This list is subject to change as new assays are validated.
Assay Assay
Adrenocorticotropic hormone (ACTH) Hepatitis C Antibody (HCV)
Amyloid beta 1-42 HIV Ag/Ab combo (cHIV)
anti-cyclic citrullinated peptides (CCP) Homocysteine
Anti-Hepatitis B e-antigen (a-Hbe) Human Chorionic Gonadotropin (beta-hCG)
Anti-Mullerian Hormone (AMH) Inhibin A
Anti-thyroglobulin antibody, quantitative (ATG) Insulin
Anti-thyroid peroxidase (ATPO), quant Insulin-Like Growth Factor 1 ( IGF-1)
Beta2 Microglobulin Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3)
Beta-crosslaps Interleukin-6 (IL-6)
CA 19-9 N Terminal ProBNP (NT proBNP)
CA15-3 Osteocalcin
CA19-9 Parathyroid Hormone (PTH),Intact
Calcitonin Placental Growth Factor (PIGF)
C-peptide Procalcitonin
Creatine Kinase (CK)MB Procollagen I Intact N-Terminal (P1NP)
Direct Renin Prolactin
Estradiol Sex hormone-binding globulin (SHBG)
Free T4 Soluble fms-like tyrosine kinase-1 (sFlt-1)
Gastrin Thyroglobulin
Hepatitis A antibody Total (HAVT) Total T3
Hepatitis B core Antibody (HBc Ab) Total Tau
Hepatitis B Core IgM Antibody (HBc IgM Ab) Troponin I Ultra
Hepatitis B e Antigen (HBe Ag) Troponin T
Hepatitis B surface Antibody Qual (anti-HBs II ) Troponin T, Gen 5
Hepatitis B surface Antibody Quant (HBs Ab Quant) Troponin T-hs
Hepatitis B Surface Antigen (HBs Ag)
English_Biotin Interference_Update: 20120430 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
INSTRUCTIONS FOR COMPLETING REQUISITION FORMS
Please complete all the required information with a blue or black ball point pen. Improper Requisition Notations:
#$.$)!*-(/$*)$.- ,0$- !*-+/$ )/$ )/$‫ݦ‬/$*))- .0'/- +*-/$)"ю
Any errors or missing details with regard to patient demographics will

! 0. '4$)/# - +*-/$)"*!/# - .0'/.0)/$'$)!*-(/$*)$.1 -$‫ ݦ‬ѓ
Make sure and use the correct format or 2# )(-&$)"/# # &*3 .ѓ
Proper Requisition Notations:
Accession No. THE ACCESSION NUMBER IS THE

REFERENCE NUMBER FOR «Bar_req»
«R
Requisition_n» COMMUNICATION WITH LABCORP.
Labcorp Central Laboratory Services LP
8211 SciCor Dr. VISIT: XXX
Indianapolis, IN 46214-2985
Tel: 866.762.6209
VISIT (CHECK ONE ; OR :)
Return this page with Samples VISIT: VISIT 1_XXX (PVC=1)

VISIT 2
Check one or
VISIT 3 Visit (if applicable). See above.
Laboratory Requisition Form SUBJECT/PATIENT INFORMATION
Page 2 of 3 Pharmaceutical Company_XXX
XXX-part Protocol: XXX XXX
- 1. Patient Number
Investigator : «Inv_n» Site Number Subject Number
Birthdate Day Month Year
Instructions:
Complete year
0 1 J AN 2. Birthdate
Complete all boxes on this requisition with a blue or Male Female
Sex
black ball point pen. Failure to complete all boxes will
delay reports. 8 2. Sex (Check appropriate box)
COLLECTION INFO
ORMATION
Please check that all patient identifiers are complete,
consistent and correct, and that each container has the Collection Date Day Month Year 3 Specimen Collection Date
Complete month field in English
same accession number, when packing specimens for (Example: 01 JAN 2001)
shipment!
3. Specimen Collection Time
24 Hour Clock
Collection Time
(Record Midnight as 23:59) :
THIS SECTION TO BE COMPLETED BY SITE PERSONNEL ONLY
Requisition Completed by Name and phone number of the person
Full name in capital letters
Phone number completing the requisition
Of the person completing the requisition
Is subject a female of childbearing potentiall?

(Check one ; or : - mandatory for females)
N/A Check the appropriate box (if
Yes No
If answer is “YES”, the Serum Beta hCG will be automatically performed. No additional applicable to your site). See above.
serum required.
Patient weight:
kg Write in appropriate number
(Mandatory)
(if applicable to your site)
Collection Date Collection Time Not
XXX
XXX
(DD-MMM-YYYY) (24 hr clock) Collected 1. Information required for patient

Timepoint : X $ )/$‫ݦ‬/$*)ю
Timepoint : X 2. Information required in order to
Mark the Not Collected box when the time point was not able to be collected. +-*1$ " )" ) -!*-.+ $‫ݦ‬
OPTIONAL TESTING - Please mark the box((es) or to ensure proper ordering of optional test(s)! reference ranges
If you fail to mark the checkbox, testing may be ordered per Labcorp policy without investigator notification.
3. Information required to calculate
Test Group_XXX Test Group_XXX Test Group_XXX
specimen stability.
Comments:
For Labcorp Use Only Optional Testing. Check Appropriate

Employee Tube Count
Validation
Internal Comments: box (if applicable)
Visa Amb Frz Refrig Slides
Write your comments here

WHITE COPY- LABCORP YELLOW COPY-XXX PINK COPY-INVESTIGATOR
«Bar_req» «Label_6» ADDITIONAL TESTING IS NOT ALLOWED «Bar_req» For Labcorp Central Laboratory
1 XXXXXX PLEASE DO NOT RETURN EMPTY CONTAINERS TO LABCORP. XX XXXXXX Services internal use only. Please do
not write in this section.
Optional Testing:
Please check the box (es) to ensure proper ordering of optional test(s)! If you fail to mark the checkbox, testing may be ordered per Labcorp
Central Laboratory Services policy without investigator notification. If you initially mark the requisition to order the optional test and would
like to cancel, please draw a single line through the marked test then initial, date, and note that the “test was marked in error”.
English_Instructions for Completing Requisition Forms_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
«Requisition_n»»
REFERENCE NUMBER FOR
COMMUNICATION WITH LABCORP.
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209
Laboratory Requisition Form

Page 1 of 2
2-part
Investigator: «Inv_n»» VISIT: SCREENING
DO NOT RETURN THIS PAGE
Testing For This Visit
Please refer to the Laboratory Manual for detailed sample collection, preparation, and handling instructions.
Associated Test Groups(s) Draw Container Return Container Shipment Condition
CTDNA PROCESSING BASELINE,

2 x 10.0 mL Streck Cell-Free DNA tubes, 2 x bubble bags Ambient
SM02/ CTDNA BASELINE
SM06/ WHOLE BLOOD DNA 1 x 6.0 mL lavender top EDTA tube Frozen
SM07/ WHOLE BLOOD RNA 1 x 2.5 mL PAXgene™ blood RNA tube, 1 x bubble bag Frozen
SM08/ CIRCULAT SOLUBLE FACTOR 1 x 4.0 mL lavender top EDTA tube 2 x cryovials Frozen
No NCR «Label_6» «Bar_req»

Keep on file for your records. DO NOT return to Labcorp.
1 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209
Return this page with Samples VISIT: SCREENING

SUBJECT/PATIENT INFOR
RMATION
Ecode E «Inv_n»
Laboratory Requisition Form Site Number Subject Number
Page 2 of 2
AstraZeneca UK Limited Birthdate Day Month Year
2-part 0 1 J U L
Investigator: «Inv_n» Sex Male
Instructions:
8
Complete all boxes on this requisition with a blue or black COLLECTION INFORMATIO
ON
ball point pen. Failure to complete all boxes will delay Collection Date Day Month Year
reports. Complete month field in English

(Example: 01 JAN 2001)
24 Hour Clock
Please check that all patient identifiers are complete, Collection Time
consistent and correct, and that each container has the (Record Midnight as 23:59) :
same accession number, when packing specimens for
THIS SECTION TO BE CO
OMPLETED BY SITE PERSONNEL ONLY
shipment!
Requisition Completed By
Phone Number
Of the person completing the
requisition
Comment
For Labcorp Use Only

Employee Tube Count Internal Comments
Validation
WHITE COPY--LABCORP PINK COPY--INVESTIGATO

OR
«Bar_req» «Label_6» ADDITIONAL TESTING ISS NOT ALLOWED «Bar_req»
1 524790 PLEASE DO NOT RETURN EMPTY CONTAINERS TO LABCORP. JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 4
2-part
Investigator: «Inv_n»» VISIT: MANDATORY FFPE BLOCK
SM04/ ARCH/NEW FFPE H&E SLIDE* 1 x 60 mL yellow cap specimen container, 1 x slide mailer, 2 x labels with AP Bar Ambient
SM09/ ARCH/NEW FFPE BLOCK 1 x 60 mL yellow cap specimen container, 1 x slide mailer, 2 x labels with AP Bar Ambient
SM11/ PATHOLOGY REPORT* 1 x envelope, 1 x label Ambient
* Conditional
In order to comply with the General Data Protection Regulation (GDPR), it is MANDATORY to redact all personal identifiable
information when submitting Anatomic Pathology samples and/or pathology reports.
Please enter “01 Jan 2000” for “Original Collection Date” if actual collection date is unknown.

T-1 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209
Return this page with Samples VISIT: MANDATORY FFPE BLOCK

RMATION
APH Ecode E «Inv_n»
Page 2 of 4
2-part 0 1 J U L
Instructions:
8
ON
ball point pen. Failure to complete all boxes will delay Requisition Completion Date Day Month Year

24 Hour Clock
Please check that all patient identifiers are complete, Requisition Completion Time
consistent and correct, and that each container has the (Record Midnight as 23:59) 00:01
shipment!
Phone Number
requisition

Validation

OR
APH Return this page with Samples APH
T-1 524790 PLEASE DO NOT RETURN EMPTY CONTAINERS TO LABCORP. JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209
Return this page with Samples

APH VISIT: MANDATORY FFPE BLOCK
Laboratory Requisition Form Ecode E «IInv_n»
Page 3 of 4 Site Number Subject Number
2-part Requisition Completion Date Day Month Year
Investigator: «Inv_n»» (Example: 01 JAN 2001)
Mandatory for all Tissue Specimens Submitted
Diagnosis? Prostate Cancer (mCRPC)
Biopsy / Resection Collection Date (DD-MMM-YYYY) _____________________
Date?
Which type of tumor sample was FFPE Block
collected?
How many blocks submitted? _________________ N/A (slides submitted)
Block ID
(Sample ID from Pathology Report
Form)
Prostate
Primary Tumor Location? Other_________________
N/A (metastatic Tumor submitted)
N/A (primary Liver Lung
Tumour
Metastatic Tumor Location? submitted)
Lymph Node Prostate Gland Skin
Spleen Other_________________
Tissue Biopsy
Collection Method?
Excision/Resection Biopsy
Fixative used?? 10% Neutral Buffered Formalin (NBF)
(Continued on next page)

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

APH VISIT: MANDATORY FFPE BLOCK
(Continued from previous page)
<6 hrs 6 to <12hrs

12 to <24 hrs 24 to <48 hrs
Formalin fixation time?
48 to <72 hrs >72 hrs
Unknown
MANDATORY FFPE BLOCK
Mark the appropriate box below.
Condition Sample
Mark this box if SM04/ ARCH/NEW FFPE H&E SLIDE sample is

submitted.
H&E SLIDE
If a pathology report is available for the embedded block, the report

should be sent to LabCorp. PATHOLOGY REPORT
Mark this box if SM11/ PATHOLOGY REPORT sample is submitted.
Comment

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 4
2-part
Investigator: «Inv_n»» VISIT: MANDATORY FFPE SLIDES 1-5
5 (IHC)
SM10/ ARCH/NEW FFPE SLIDES 1-5 1x 25 slides empty solid plastic box, 1 x microscope slide, 1 x label with AP Bar Ambient
* Conditional

T-2 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209
Return this page with Samples VISIT: MANDATORY FFPE SLIDES 1-5
5 (IHC)
RMATION
Page 2 of 4
2-part 0 1 J U L
Instructions:
8
ON

24 Hour Clock
shipment!
Phone Number
requisition

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

APH VISIT: MANDATORY FFPE SLIDES 1-5 (IHC)
Date?
Which type of tumor sample was Unstained Slides
collected?
Block ID
Form)
How many slides submitted? _________________ N/A (slides submitted)

Date (DD-MMM-YYYY) _____________________
Date of Slide Sectioning?
N/A (block submitted)
4 μm
Section Micron Thickness?
Not applicable (block submitted)
Prostate
N/A (primary Tumour submitted) Liver Lung
Metastatic Tumor Location? Lymph Node Prostate Gland Skin
Spleen Other_________________
Tissue Biopsy
Collection Method?

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

APH VISIT: MANDATORY FFPE SLIDES 1-5 (IHC)
<6 hrs 6 to <12hrs

12 to <24 hrs 24 to <48 hrs
48 to <72 hrs >72 hrs
Unknown
MANDATORY FFPE SLIDES
Condition Sample
If a pathology report is available for the embedded Slides, the report should be sent to LabCorp.
PATHOLOGY REPORT
Comment

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 4
2-part
Investigator: «Inv_n»» VISIT: MANDATORY FFPE SLIDES 6-3
30 (NGS)
SM16/ ARCH/NEW FFPE SLD 6-30 1x 25 slides empty solid plastic box, 1 x microscope slide, 1 x label with AP Bar Ambient
* Conditional

T-3 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209
Return this page with Samples VISIT: MANDATORY FFPE SLIDES 6-3
30 (NGS)
RMATION
Page 2 of 4
2-part 0 1 J U L
Instructions:
8
ON

24 Hour Clock
shipment!
Phone Number
requisition

Validation

OR
«Bar_req» «Label_6» ADDITIONAL TESTING IS NOT ALLOWED «Bar_req»
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

APH VISIT: MANDATORY FFPE SLIDES 6-30 (NGS)
Date?
Which type of tumor sample was Unstained Slides
collected?
Block ID
Form)
How many slides submitted? ________________ N/A (slides submitted)

Date (DD-MMM-YYYY) _____________________
Date of Slide Sectioning?
N/A (block submitted)
4 μm
Section Micron Thickness?
Not applicable (block submitted)
Prostate
Metastatic Tumor Location? Lymph Node Prostate Gland Skin
Spleen Other_________________
Tissue Biopsy
Collection Method?

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

APH VISIT: MANDATORY FFPE SLIDES 6-30 (NGS)
<6 hrs 6 to <12hrs

12 to <24 hrs 24 to <48 hrs
48 to <72 hrs >72 hrs
Unknown
MANDATORY FFPE SLIDES
Condition Sample
If a pathology report is available for the embedded Slides, the report should be sent to LabCorp.
PATHOLOGY REPORT
Comment

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 3
2-part
Investigator: «Inv_n»» VISIT: OPTIONAL TUMOUR BIOPSY
SM12/ SINGLE BIOPSY BLOCK*,

2 x 60 mL yellow cap specimen containers, 2x cassettes Ambient
SM14/ PAIRED BIOPSY BLOCK*
SM13/ SINGLE BIOPSY SNAP*,
2 x cryovials Frozen
SM15/ PAIRED BIOPSY SNAP*
* Conditional

T-7 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209
Return this page with Samples VISIT: OPTIONAL TUMOUR BIOPSY

APH
Paired Biopsy at Pre Cycle 1 Day 1 (PVC=PREC1D1)
Laboratory Requisition Form Paired Biopsy at Cycle 1 Day 1 (PVC=C1D1)
Page 2 of 3
AstraZeneca UK Limited Paired Biopsy at Cycle 1 Day 17 (PVC=C1D17)
2-part
Protocol: D361EC00001 Paired Biopsy at Cycle 1 Day 18 (PVC=C1D18)
Investigator: «Inv_n» Paired Biopsy at Cycle 1 Day 19 (PVC=C1D19)
Instructions: Single Biopsy at Disease Progression (PVC=PROGRESS)
Complete all boxes on this requisition with a blue or black
RMATION
ball point pen. Failure to complete all boxes will delay
reports. Ecode E «Inv_n»
Site Number Subject Number
Day Month Year

Please check that all patient identifiers are complete, Birthdate
consistent and correct, and that each container has the 0 1 J U L
same accession number, when packing specimens for Male
Sex
shipment!
8
COLLECTION INFORMATIO
ON
Day Month Year
Requisition Completion Date
24 Hour Clock
Requisition Completion Time
(Record Midnight as 23:59) 00::01
Phone Number
requisition

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

APH VISIT: OPTIONAL TUMOUR BIOPSY
Biopsy / Surgical
Date (DD-MMM-YYYY) _____________________
Resection Date
Prostate
Primary Tumor Location Other________
N/A
Metastatic Tumor Location Lymph Node Prostate Gland Skin
Spleen Other________
OPTIONAL TUMOUR BIOPSY
Single or paired biopsies are optional biomarker analysis. Either submit a single block and snap biopsy or a paired block and snap biopsy.
Condition Sample
A single tissue block is submitted for optional biomarker analysis.

Mark this box if SM12/ SINGLE BIOPSY BLOCK sample is submitted. SINGLE BLOCK
A single snap biopsy is submitted for optional biomarker analysis.
Mark this box if SM13/ SINGLE BIOPSY SNAP sample is submitted. SINGLE SNAP BIOPSY
A paired tissue block is submitted for optional biomarker analysis.
Mark this box if SM14/ PAIRED BIOPSY BLOCK sample is submitted. PAIRED BLOCK
A paired snap biopsy is submitted for optional biomarker analysis.
Mark this box if SM15/ PAIRED BIOPSY SNAP sample is submitted. PAIRED SNAP BIOPSY
Comment

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 2
2-part
Investigator: «Inv_n»» VISIT: CYCLE 1 DAY 1
CTDNA PROCESSING BASELINE,

SM02/ CTDNA BASELINE
Please usee the GX kit to collect the optional Genetic (GX) sample for patients who have provided informed consent.

2 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209
Return this page with Samples VISIT: CYCLE 1 DAY 1

RMATION
Ecode E «Inv_n»
Page 2 of 2
2-part 0 1 J U L
Instructions:
8
ON

24 Hour Clock
shipment!
Phone Number
requisition
Comment

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 2
2-part
Investigator: «Inv_n»» VISIT: GX
SM01/ GX SAMPLE 1 x 6.0 mL lavender top EDTA tube Frozen
This sample should ONLY be collected for patients who have provided informed consent for the optional genetic research sample..

T-6 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209
Return this page with Samples VISIT: GX

RMATION
Ecode E «Inv_n»
Page 2 of 2
2-part 0 1 J U L
Instructions:
8
Complete all boxes on this requisition with a blue or black COLLECTION INFORMATION

24 Hour Clock
shipment!
Phone Number
requisition
Comment

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 2
2-part
AZD5363 PK 1HR POST 1 x 2.0 mL lavender top EDTA tube 1 x cryovial Frozen
PK samples will be collected with an allowance window period as follow:

1H Post-dose: After Capivasertib dose: ± 15 min
2H Post-dose: After Capivasertib dose: ± 15 min
4H Poste-dose: After Capivasertib dose: ± 30 min
Please ensure to write the collection date and time on the requisition.
All samples co
ollected outside of the window period will not be considered a protocol deviation.

3 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

RMATION
Ecode E «Inv_n»
Page 2 of 2
2-part 0 1 J U L
Instructions:
8
ON

24 Hour Clock
shipment!
Phone Number
requisition
AZD5363 PK
(DD-MMM-YYYY) (24 hr clock) Collected
1H : X
2H : X
4H : X
Mark the Not Collected box when the time point was not able to be collected.
Comment

Validation

OR
«Bar_req» «Label_6» ADDITIONAL TESTING IS NOT ALLOWED «Bar_req»
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 2
2-part
CTDNA PROCESSING NON-BASELINE,

SM03/ CTDNA NON-BASELINE
AZD5363 PK PRE-DOSE 1 x 2.0 mL lavender top EDTA tube 1 x cryovial Frozen

Pre-Dose: Before Capivasertib dose: up to -90 min
All samples collected outside of the window period will not be considered a protocol deviation.

4 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

RMATION
Ecode E «Inv_n»
Page 2 of 2
2-part 0 1 J U L
Instructions:
8
ON

24 Hour Clock
shipment!
Phone Number
requisition
AZD5363 PK
Pre : X
Comment

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 2
2-part


Pre-Dose: Before Docetaxel infusion: up to -90 min

5 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

RMATION
Ecode E «Inv_n»
Page 2 of 2
2-part 0 1 J U L
Instructions:
8
ON

24 Hour Clock
shipment!
Phone Number
requisition
AZD5363 PK
Pre : X
Comment

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 2
2-part


Pre-Dose: Before Docetaxel infusion: up to -90 min

6 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

RMATION
Ecode E «Inv_n»
Page 2 of 2
2-part 0 1 J U L
Instructions:
8
ON

24 Hour Clock
shipment!
Phone Number
requisition
AZD5363 PK
Pre : X
Comment

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 2
2-part


7 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

RMATION
Ecode E «Inv_n»
Page 2 of 2
2-part 0 1 J U L
Instructions:
8
ON

24 Hour Clock
shipment!
Phone Number
requisition
Comment

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 2
2-part
Investigator: «Inv_n»» VISIT: EVERY 16 WEEKS FROM D1C1


T-4 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209
Return this page with Samples VISIT: EVERY 16 WEEKS FROM D1C1
Cycle _ _ Day _ _ (PVC=C_ _ D_ _)
Laboratory Requisition Form SUBJECT/PATIENT INFOR
RMATION
Page 2 of 2
2-part Ecode E «Inv_n»
Protocol: D361EC00001 Site Number Subject Number
Investigator: «Inv_n» Day Month Year
Birthdate
Instructions: 0 1 J U L
Complete all boxes on this requisition with a blue or black Male
Sex
ball point pen. Failure to complete all boxes will delay
8
reports.
ON
Day Month Year
Please check that all patient identifiers are complete, Collection Date
consistent and correct, and that each container has the Complete month field in English
24 Hour Clock
shipment! Collection Time
THIS SECTION TO BE COMPLETED BY SITE PERSONNELL ONLY
Phone Number
requisition
Comment

Validation

OR
«Requisition_n»»
«Bar_req»

Page 1 of 2
2-part
Investigator: «Inv_n»» VISIT: CTC EPIC NA/LATAM
CTC EPIC NA/LATAM 1 x 10.0 mL Streck Cell-Free DNA tube Ambient
Send the following samples CTC EPIC NA/LATAM to:

Epic Sciences
Attn: (Partner Protocol # D361EC00001 / Epic Internal ID)
9381 Judicial Dr., Suite 200
San Diego, CA 92121
USA
Email: partners@epicsciences.com
A copy of the requisition form(s) should be shipped with the sample.
DO NOT SHIP TO LABCORP CLS

T-8 524790 JPT 220122
«Requisition_n»»
«Bar_req»
VISIT: CTC EPIC NA/LATAM
Do NOT Return to Labcorp VISIT (CHECK ONE ; OR :)
CTC EPIC Cycle 1 Day 1 (PVC=C1D1)
Laboratory Requisition Form CTC EPIC PROGRESSION (PVC=PROGRESS)
Page 2 of 2
AstraZeneca UK Limited SUBJECT/PATIENT INFOR
RMATION
2-part
Protocol: D361EC00001 Ecode E «Inv_n»
Investigator: «Inv_n» Site Number Subject Number
Day Month Year

Instructions: Birthdate
Complete all boxes on this requisition with a blue or black 0 1 J U L
ball point pen. Failure to complete all boxes will delay Sex Male
reports. 8
ON
Please check that all patient identifiers are complete,
Day Month Year
consistent and correct, and that each container has the Collection Date
shipment! 24 Hour Clock
Collection Time
Phone Number
requisition
Comment

Validation
WHITE COPY--REFERRAL LAB PINK COPY--INVESTIGATO

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 2
2-part
Investigator: «Inv_n»» VISIT: DISEASE PROGRESSION


T-5 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209
Return this page with Samples VISIT: DISEASE PROGRESSION

RMATION
Ecode E «Inv_n»
Page 2 of 2
2-part 0 1 J U L
Instructions:
8
ON

24 Hour Clock
shipment!
Phone Number
requisition
Comment

Validation

OR
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209

Page 1 of 2
2-part
Investigator: «Inv_n»» VISIT: DISCONTNUATION

SM07/ WHOLE BLOOD RNA 1 x 2.5 mL PAXgene™ blood RNA tube, 2 x bubble bags Frozen

T 524790 JPT 220122
«Requisition_n»»
«Bar_req»
8211 SciCor Dr.
Tel: 866.762.6209
Return this page with Samples VISIT: DISCONTNUATION

RMATION
Ecode E «Inv_n»
Page 2 of 2
2-part 0 1 J U L
Instructions:
8
ON

24 Hour Clock
shipment!
Phone Number
requisition
Comment

Validation

OR
T 524790 PLEASE DO NOT RETURN EMPTY CONTAINERS TO LABCORP. JPT 220122
SECTION BREAK
GENERAL INFORMATION FOR PACKAGING AND SHIPPING
Labcorp Central Laboratory Services shipping material is designed in accordance with IATA
! regulations!
Air waybills and shipping labels may only be used one time!
Consolidated Shipments: (All Countries except Japan)

For your convenience, shipping materials provided by Labcorp Central Laboratory Services are not protocol specific.
Please consolidate sample shipments of like condition (ambient or frozen) to Labcorp Central Laboratory Services
whenever possible.
Courier Pick-up Information

Prior to shipping your first specimens, we recommend that you call the courier to define your site as a new pickup
location for shipments to Labcorp Central Laboratory Services. This will facilitate the process when you are ready for
your first shipment. Labcorp Central Laboratory Services will be billed directly for all transportation costs.
Please be sure to inquire about your local service schedules and the latest time of day that you can call to arrange
for a pick-up. Timely pick-ups will ensure samples are shipped within stability for testing.
While most samples are specified to be shipped day of collection, we realize there are times when circum-stances
do not permit this to occur.
• / ȅ -)**).(+' *'' /$*)ȅ -'./''ѣ$)*-+$&ѣ0+1$'$'$/4!*-*0-$ -. -1$
• Dry ice may not be available the same day as frozen sample collection
• Pick-up is missed by courier service
In the event that samples cannot be shipped the day of collection, they should be stored under the condition they
are to be shipped. These samples should then be shipped to Labcorp Central Laboratory Services the very next day
of availability.
• AMBIENT samples should remain at ambient temperature – Do not refrigerate
• REFRIGERATED samples should remain between 2°C and 8°C
• FROZEN samples should remain frozen at the appropriate temperature
For Latin America, Australia, New Zealand and Asia (except Japan):
When contacting courier, also inquire about local export requirements.
Shipping boxes (Countries except Japan when BML takes care of the sample pick-up)
Containers must be securely packed in their shipping box. Please check by gently shaking the box after packaging.
If the containers are loose, repack the box by filling the empty spaces with paper.
Materials Safety Data Sheets

MSDS sheets for chemical products used in Labcorp Central Laboratory Services studies may be accessed at the
following website:
<http://sds.Labcorp Central Laboratory Services.com>. The website allows you to search for the MSDS sheets by
product name or container code. If you have any questions, please contact Labcorp Central Laboratory Services
EHS at +13172735369.
English_General Information for Packaging and Shipping_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.
PACKAGING PROCEDURES - CONSOLIDATING SHIPMENTS
AMBIENT, REFRIGERATED OR FROZEN

BIOLOGICAL SUBSTANCE, CATEGORY B
Notify your courier of your shipment!
Problems/questions concerning packaging procedures? Contact &RYDQFH using our toll-free number.
When possible, please consolidate shipments

Consolidating your sample shipments is a way to save you and your staff time by
reducing the number of shipping cartons prepared for shipment to &RYDQFH.
! Your sponsor also benefits by reduced transportation cost for protocols.
Send samples for more than one patient and/or more than one sponsor or
protocol in a single shipment.
NOTE: Actual shipping cartons

may differ from pictures
Please note that shown here.
patient samples can

ONLY be shipped back
to Covance with the
appropriate outer
carton.
VHH¿JXUHWR
WKHULJKW
Key points:
Always consolidate patient sample shipments by condition: ambient, refrigerated, or frozen.
Be sure each patient’s samples and the completed requisition for that patient are packaged together in their own
Specimen Collection Bag, by shipping condition.
The Ambient shipping box will hold 2 to 4 lab kits containing ambient samples.
The Frozen shipping box will hold 1 to 2 Specimen Collection Bags of samples per frozen shipment.
Be sure to allow ample space for dry ice in your frozen shipments as you will need 3 kgs of dry ice per shipment
(2 Kg for North America) when using &RYDQFH supplied packaging. Use of courier supplied packaging may require more
dry ice. Please follow your courier recommendation for the amount of dry ice to use.
Use the appropriate air waybill depending on sample condition (ambient/refrigerated or frozen).
Please ensure the outer packaging used for transport of any Biological Substance, Category B material is marked and
labeled according to the ICAO/IATA requirements.
EXAMPLE OF CONSOLIDATED SHIPMENT
Sponsor #1
Sponsor #3
Sponsor #2
Note: Contact &RYDQFH to inquire about special packaging designed to send large numbers
of samples per shipment if you are participating in a study with high daily patient volume.
English_Packaging Procedure Consolidated Shipments_Update: 20131118 ©2012 &RYDQFH CLS
PACKAGING PROCEDURES - ALL COUNTRIES
AMBIENT
!
Problems/questions concerning packaging procedures? Call us using our toll-free number.
1. Insert the tube(s) into the 2. Fold the white copy of the 3. 7DNH D *HO 3DN DQG ¿OO LW WR
Specimen Collection Bag completed requisition form and the indicator line with cool tap
containing an absorbent pack. place it into the pocket on the water. Seal the bag.
3ODFH EDJ RQ ÀDW VXUIDFH WR reverse side of the Specimen
minimize wrinkles, especially at Collection Bag. The bar code
adhesive sealing area. Remove must be visible.
tape liner to expose adhesive.
Fold along bag opening so star
is inside of box shape. Press
from center to edge to seal.
Do NOT place sharps into
collection bag.
4. Lightly press the absorbent 5. Place the Specimen Collection 6. Place the Gel Pak into the white
pack to expel its contents. Bag on top of the Gel Pak. kit box. Do NOT ship sharps to
Massage the bag until water Wrap the Gel Pak around the Covance.
has been absorbed and a gel Specimen Collection Bag,
material has formed. sandwiching the specimens
Expel the air from the Gel Pak in the middle. Do not insert
and reseal. the specimen containers
directly into the Gel Pak!
Important: Ensure the Hema-
tology sample is placed in
the fold of the Gel Pak.
Continued on next page...
English_Packaging Procedure Ambient_Update: 20190429 ©2003-2017 Covance CLS
AMBIENT
...continued from previous page.
Note:
If the kit box is too large to place
in the ambient shipping carton,
wrap a rubberband around the Gel
Pak. Place the Gel Pak containing
the specimen collection bag inside
the large zip bag.
7. Insert the kit into the zip bag. 8. Place the zip bag into the Place the zip bag into the shipping
shipping carton. Fill empty carton. Fill empty spaces with
spaces with cushioning material cushioning material (i.e. paper).
(i.e. paper).

may differ from
pictures shown here.
9. Seal the shipping carton 10. US domestic shipments:&RPSOHWHDQGDI¿[WKHDLUZD\ELOOWRWKH

VHFXUHO\ $I¿[ WKH ODEHO ZLWK designated spot on the box.
your address on the box as Rest of world: Insert the shipping documentation into the
indicated on the picture above. transparent pouch ensuring that the airway bill remains visible.
Note: Your shipment may Affix the pouch to the cardboard box on the “Place airway bill here”
be delayed if the label is not section.
DI¿[HGWRWKHER[
GEL PAK SAFETY TIPS
IMPORTANT: INSTRUCTIONS FOR USE
Please take the specimen collection bag and WRAP the Gel Pak AROUND the specimen
place it on the Gel Pak. collection bag.
CAUTION:
DO NOT put the specimen collection bag DO NOT put the tubes DIRECTLY INTO
INTO the Gel Pak! the Gel Pak!
FROZEN
! Ship no more than 120 mL in a Specimen Collection bag and no more than two Specimen
Collection bags per 2.0 kilograms of dry ice!
1. Insert the tube(s) into the 2. )ROG WKH ZKLWH FRS\ RI WKH 3. )LOO KDOI RI WKH VW\URIRDP
Specimen Collection Bag FRPSOHWHGUHTXLVLWLRQIRUPDQG container with dry ice and
containing an absorbent pack. place it into the pocket on the insert the Specimen Collection
3ODFH EDJ RQ ÀDW VXUIDFH WR UHYHUVH VLGH RI WKH 6SHFLPHQ %DJV7KHQFRPSOHWHO\¿OOWKH
minimize wrinkles, especially at Collection Bag. The bar code VW\URIRDP FRQWDLQHU ZLWK GU\
adhesive sealing area. Remove must be visible. ice.
tape liner to expose adhesive. 'R 127 VKLS VKDUSV WR
Fold along bag opening so star &RYDQFH.
LV LQVLGH RI ER[ VKDSH 3UHVV
IURPFHQWHUWRHGJHWRVHDO'R
NOT place sharps into collection
bag.
4. 5HSODFHWKHVW\URIRDPOLG
Continued on next page...

3UREOHPVTXHVWLRQVFRQFHUQLQJSDFNDJLQJSURFHGXUHV"&DOOXVXVLQJRXUWROOIUHHQXPEHU
English_Packaging Procedure Frozen Specimen_Update: 20200402 ©2003 - 2020 &RYDQFH CLS
FROZEN
FRQWLQXHGIURPSUHYLRXVSDJH

PD\GLIIHUIURPSLFWXUHV
shown here.
5. Seal the shipping carton securely. $ႈ[ WKH 6. US domestic shipments: &RPSOHWH DQG Dႈ[ WKH
label with your address on the box as indicated shipping document to the designated spot on the box.
on the picture above. Rest of world: Insert the shipping documentation into
Note: Your shipment may be delayed if the the transparent pouch ensuring that the airway bill
label is not affixed to the box. UHPDLQVYLVLEOH$IIL[WKHSRXFKWRWKHFDUGERDUGER[
on the “Shipping documents” section.
English_Packaging Procedure Frozen Specimen_Update: 20200402 ©2003 - 2020 &RYDQFH CLS
PACKAGING PROCEDURES - ALL COUNTRIES EXCEPT
ASIA PACIFIC/LATIN AMERICA
COMBINED AMBIENT-FROZEN
! Problems/questions concerning packaging procedures? Call us using our toll-free number.
US/Canada/Puerto Rico: Ship no more than 10 specimens per 2.0 kilograms of dry ice!
Rest of World: Ship no more than 10 specimens per 3 kilograms of dry ice!
1. Place the tube(s) into a 2. Fill half of the styrofoam 3. Replace the styrofoam lid.
Specimen Collection Bag container with dry ice and
containing an absorbent pack. insert the Specimen Collection
3ODFH EDJ RQ ÀDW VXUIDFH WR %DJV 7KHQ FRPSOHWHO\ ILOO WKH
minimize wrinkles, especially styrofoam container with dry ice.
at adhesive sealing area.
Remove tape liner to expose Do NOT ship sharps to &RYDQFH.
adhesive. Fold along bag
opening so star is inside of
box shape. Press from center
to edge to seal. Do NOT place
sharps into collection bag.
4. Place the cardboard spacer 5. For the ambient tubes, repeat 6. 7DNHD*HO3DNDQG¿OOLWWRWKH
on top of the styrofoam. step 1. Then fold the white copy indicator line with cool tap water.
of the completed requisition form Seal the bag.
and place it into the pocket on
the reverse side of the Specimen
Collection Bag. The bar code
must be visible.
7. Lightly press the absorbent 8. Place the Specimen Collection

pack to expel its content. Bag on top of the Gel Pak. Wrap Important: Ensure the Hema-
Massage the bag until water the Gel Pak around the Specimen tology sample is placed in the
has been absorbed and a gel Collection Bag, sandwiching the fold of the gel pak.
material has formed. Expel specimens in the middle. Do not
the air from the Gel Pak and insert the specimen containers
reseal. directly into the Gel Pak! Continued on next page...
English_Packaging Procedure Combo Ambient Frozen_Update: 20200402 ©2003 - 2020 &RYDQFH CLS
PACKAGING PROCEDURES - ALL COUNTRIES EXCEPT
ASIA PACIFIC/LATIN AMERICA
COMBINED AMBIENT-FROZEN
...continued from previous page.
9. Place the specimen collection 10. Insert the kit into the zip bag. 11. Place the zip bag into the
bag wrapped in the Gel Pak into cardboard box. Fill empty
the white kit box. Do NOT ship spaces with cushioning
sharps to &RYDQFH. material (i.e. paper).
Note:
If the kit box is too large to place
in the shipping carton, wrap a
rubber band around the Gel Pak.
Place the Gel Pak containing the
specimen collection bag inside the
large zip bag.
Place the zip bag into the shipping
carton. Fill empty spaces with
cushioning material (i.e. paper).

may differ from pictures
shown here.
12. 6HDO WKH VKLSSLQJ FDUWRQ VHFXUHO\ $ႈ[ WKH 13. US domestic shipments: &RPSOHWH DQG Dႈ[ WKH
label with your address on the box as indicated airway bill to the designated spot on the box.
on the picture above. Rest of world: Insert the shipping documentation
Note: Your shipment may be delayed if into the transparent pouch ensuring that the airway
the label is not affixed to the box. bill remains visible. Affix the pouch to the cardboard
Verify the amount of dry ice in kilograms on box on the “Shipping documents” section.
the UN1845 label.
English_Packaging Procedure Combo Ambient Frozen_Update: 20200402 ©2003 - 2020 &RYDQFH CLS
SHIPPING DOCUMENTS
ARE PROVIDED IN LARGE COLOR-CODED ENVELOPES
The protocol specific shipping documents are provided in the appropriate envelope with the start-up
! material. They are not automatically resupplied.
Order additional envelopes by using the web address/link http://www.covance.com/kitordering or
by contacting Covance CLS.
The envelope with text in RED

contains your shipping documents
for ambient, refrigerated or combo
ambient-refrigerated specimens.
The envelope with text in BLUE

contains your shipping documents
for frozen or combo ambient-frozen
specimens.
The envelope with

text in GREEN
contains your shipping
documents for
miscellaneous
(including any special
shipping documents
not included in the
two other envelopes)
and/or dangerous
goods specimens
English_Shipping Documents_Update: 20140815 ©2003 Covance CLS
SHIPPING DOCUMENTS - USA
ALL TEMPERATURES
Biological Substance Category B
NOTE: Calling UPS at 1-866-961-3790 to schedule your pick-up and the special routing address
allows UPS to provide the highest level of service and ensures the safety and stability of
samples.
6SHFLDO
5RXWLQJ
$GGUHVVIRU
&RYDQFH
6KLSPHQWV
ple
am
Ex
Sites can create and print the Covance UPS Express Critical shipping labels on-demand via the web at
https://www.covance.com/customers/investigators/investigator-tools-and-resources/ups-express.html.
Please Note: This new service to print UPS labels is only applicable for shipments going to Covance Central
Laboratory Services in the USA.
x &RPSOHWHWKHUHTXLUHGFRQWDFWLQIRUPDWLRQ¿HOGV
x 6HOHFWWKHDSSURSULDWH³5HWXUQ7\SHÍURPWKHGURSGRZQOLVWWKHZHLJKW¿HOGZLOODXWRSRSXODWHEDVHGRQ
the “return type” chosen.
x :KHQ¿QLVKHGVHOHFW³3URFHVV6KLSPHQW´DWWKHERWWRPRIWKHVFUHHQ3ULQWD836VKLSSLQJODEHODQGDI¿[
VHFXUHO\WRWKHER[VRLWFDQQRWEHWRUQRUULSSHGZKLOHLQWUDQVLWDQGEHLQJFDUHIXOQRWWRFRYHUDQ\SUH
printed marking or label on the box.
Creation of the UPS shipping label does NOT automatically schedule sample pick-up. You must contact
the UPS Clinical Trials Support Center to schedule pickup at 866-961-3790. Inform the UPS Call Center
Representative that your package is an URGENT COVANCE MEDICAL SHIPMENT.
,I\RXKDYHTXHVWLRQVDERXWVKLSSLQJ\RXUSDFNDJHRUQHHGKHOSZLWKDQ\FRXULHUUHODWHGLVVXHSOHDVHFRQWDFW
the Covance Site Support Services team at 1-866-762-6209.
English_US Shipping Documents UPS_Update: 20171013 ©2008-2017 Covance CLS
SHIPPING DOCUMENTS - CANADA
AMBIENT / REFRIGERATED / COMBINED AMBIENT-REFRIGERATED

This is a two-part shipping label.
Part 1 - RETURNS Mon-Sat:

t $ႈ[ODEHORQVKLSSLQJER[2QHODEHOSHUVKLSSLQJER[
t No additional markings or labels are needed for shipments to deliver on Saturdays.
Part 2 - CONSIGNEE COPY – PLEASE PLACE IN POUCH:

t 3ODFHLQWRWKHSODVWLFSRXFKWKDWPXVWEHDႈ[HGWRWKHVKLSSLQJER[LQFOXGLQJWKHFRSLHVRIWKH&RPPHUFLDO
Invoice.
t Photocopy the waybill doc label or write the TRK# waybill manually for reference.
When calling to schedule your pick-up, inform the call center agent that your package is an URGENT
COVANCE MEDICAL SHIPMENT.
(QJOLVKB866KLSSLQJ'RFXPHQWV6SHFLPHQV$PELHQW)HG([&DQDGDB8SGDWH
English_US Shipping Documents Specimens Ambient FedEx Canada_Update: 20070807 ©2003 - 2020 Covance CLS
AMBIENT / REFRIGERATED / COMBINED AMBIENT-REFRIGERATED
ress
ic add
site specif
with
inted
Prepr
L E
B
M P
X A
E
C D E
<RXPXVWHQWHU
A Appropriate airway bill number
B Total number of packages
C Signature of shipper
D Printed Name
E Date
(QJOLVKB&DQDGD&RPPHUFLDO,QYRLFH$PELHQW6SHFLPHQVB8SGDWH ©2003 - 2020 Covance CLS
FROZEN / COMBINED AMBIENT-FROZEN
This is a two-part shipping label.

When shipping frozen samples with dry ice chose the shipping label that indicates ICE; refer to section A
on the consignee copy (#2).
Part 1 - RETURNS Mon-Sat:

$ႈ[ODEHORQVKLSSLQJER[2QHODEHOSHUVKLSSLQJER[
No additional markings or labels are needed for shipments to deliver on Saturdays.
Part 2 - CONSIGNEE COPY – PLEASE PLACE IN POUCH:

3ODFHLQWRWKHSODVWLFSRXFKWKDWPXVWEHDႈ[HGWRWKHVKLSSLQJER[LQFOXGLQJWKHFRSLHVRIWKH&RPPHUFLDO
Invoice.
Photocopy the waybill doc label or write the TRK# waybill manually for reference.
When calling to schedule your pick-up, inform the call center agent that your package is an URGENT
COVANCE MEDICAL SHIPMENT.
English_US Shipping Documents Frozen Combined FedEx Canada_Update: 20200617 ©2003 - 2020 Covance CLS
FROZEN / COMBINED AMBIENT-FROZEN
s
ddres
specific a
ite
with s
inted
Prepr
L E
P
B
A M
E X
C D E
You must enter:
A Write down appropriate airbill number
B Write down total number of packages
C Signature of shipper
D Name Printed
E Date
English_US Shipping Documents Frozen Combined FedEx Canada_Update: 20070807 ©2003 - 2020 Covance CLS
SECTION BREAK
REFERENCE RANGES/ALERTS AND FLAGS
The reference ranges are age, gender specific and represent a heterogeneous clinical trials patient population. Flags are
indicated in the laboratory report.
The unstated word “to” is implied by the “dash” appearing in age specific reference ranges. A range such as “0-59 years”
and “59-150 years” means: “0 up to but not including 59 years” and “59 up to but not including 150 years”.
The “H” and “L” flags will always be printed. Your sponsor may request different or additional flags than the ones listed
below. Notification of the sponsor flags will occur only if requested by the sponsor.
Note: Reference ranges and alert flags included in the Investigator Manual are for reference purposes only. Reference
ranges and alert flags which are sex and/or age specific can change during the course of a clinical trial. Therefore,
reference ranges and alert flags that print on the Labcorp Central Laboratory Services report should be used for
patient management.
Flag Represents Meaning Notification
H High Flag Patient’s result is outside of the No Notification Beyond H/L on Report
L Low Flag reference range.
HT High Telefacsimile Patient’s result is outside of the Available on eSite Access, check
LT Low Telefacsimile reference range significantly online. Also, Sponsor May Request
enough to warrant notification. Telephone Notification.
HP High Panic Patient’s result is outside of the Available on eSite Access, check
LP Low Panic reference range with potentially online and Telephone Notification to
critical implications for the Investigator Site (and Sponsor if
patient. requested).
+d Delta Patient’s current result has No Notification Beyond +d/-d on

-d Delta changed (delta) from the Report
patient’s baseline value.
EX Exclusions Patient’s value is an exclusion Notification as Directed by Sponsor

according to protocol
requirements. EX flags are
protocol specific. Investigator
should refer to the protocol to
validate the EX flag.
Reporting holds
Your laboratory reports will be held for data clarification when:
- Patient data on the requisition form is missing, incomplete, or inconsistent with previous records.
- Additional data requested on the requisition form is missing.
- A kit refers to a visit that has been received earlier or to a visit out of sequence.
When the issue has been clarified, the laboratory report will be released. In case of a clinically important alert, the
investigator in question will be contacted immediately.
English_Reference Ranges/Alerts and Flags_eSA_Update: 20210625 Copyright ©2021 Laboratory Corporation of America® Holdings. All rights reserved.

Run:26ŞJanŞ22 ReferenceRangeReport(Clinical)Page:1
9:59AM Reportedin:ConventionalUnitsProject:524790
Group:TISSUEBLOCKPROCNF30

TestEthnicSexAgeRangeAlertFlagsEffectiveDate
____________________________________________________________________________________________________________________________________________________________________________
10ŞAugŞ2010
BlkProNF30(HTT247)Both0YŞ150Y
____________________________________________________________________________________________________________________________________________________________________________
10ŞAugŞ2010
BlkID(HTT248)Both0YŞ150Y
____________________________________________________________________________________________________________________________________________________________________________
10ŞAugŞ2010
QCFFPE(HTT250)Both0YŞ150Y
____________________________________________________________________________________________________________________________________________________________________________
10ŞAugŞ2010
RptReview(HTT249)Both0YŞ150Y
____________________________________________________________________________________________________________________________________________________________________________
19ŞAugŞ2010
PathCase#(HTT305)Both0YŞ150Y
____________________________________________________________________________________________________________________________________________________________________________
10ŞAugŞ2010
#Unst+Slid(HTT254)Both0YŞ150Y
____________________________________________________________________________________________________________________________________________________________________________
10ŞAugŞ2010
D.UnstPrep(HTT260)Both0YŞ150Y
____________________________________________________________________________________________________________________________________________________________________________
10ŞAugŞ2010
FFPECom.(HTT251)Both0YŞ150Y
____________________________________________________________________________________________________________________________________________________________________________
19ŞAugŞ2010
#BlksPt(HTT306)Both0YŞ150Y

LabcorpCLSLP8211SciCorDrive,Indianapolis,INUSA46214Ş2985(317)271Ş1200FAX(317)616Ş2351

Group:CTDNAPROCESSINGBASELINE

____________________________________________________________________________________________________________________________________________________________________________
14ŞFebŞ2020
WBVolRecvd(TCT8738)Both0YŞ150YmLNoRefRng
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
Plasma(TCT7264)Both0YŞ150YmLNoRefRng
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
BuffyCoat(TCT7274)Both0YŞ150YmLNoRefRng
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
BuffyCoat(TCT7275)Both0YŞ150YmLNoRefRng
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
Date(TCT7276)Both0YŞ150Y
____________________________________________________________________________________________________________________________________________________________________________
14ŞNovŞ2019
Comment(TCT7278)Both0YŞ150Y



Group:CTDNAPROCESSINGNONŞBASELINE

____________________________________________________________________________________________________________________________________________________________________________
29ŞNovŞ2021
WBVolRecvd(TCT21371)Both0YŞ150YmLNoRefRng
____________________________________________________________________________________________________________________________________________________________________________
29ŞNovŞ2021
____________________________________________________________________________________________________________________________________________________________________________
29ŞNovŞ2021
____________________________________________________________________________________________________________________________________________________________________________
29ŞNovŞ2021
____________________________________________________________________________________________________________________________________________________________________________
29ŞNovŞ2021
____________________________________________________________________________________________________________________________________________________________________________
29ŞNovŞ2021
____________________________________________________________________________________________________________________________________________________________________________
29ŞNovŞ2021
Date(TCT21377)Both0YŞ150Y
____________________________________________________________________________________________________________________________________________________________________________
29ŞNovŞ2021
Time(TCT21378)Both0YŞ150Y
____________________________________________________________________________________________________________________________________________________________________________
29ŞNovŞ2021
Comment(TCT21379)Both0YŞ150Y



Group:CTCCELLSEARCH

____________________________________________________________________________________________________________________________________________________________________________
28ŞJulŞ2017
CTCEnumer(WFT2275)Both0YŞ150YCTC/7.5mLblood
NoRefRng


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Central Laboratory Services
Indianapolis Shanghai
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Indianapolis, IN 46214-2985 USA Zhangjiang Hi-Tech Park
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English_TableOfContents_Update: 20220122 ŽƉǇƌŝŐŚƚΞϮϬϮϭ>ĂďŽƌĂƚŽƌǇŽƌƉŽƌĂƟŽŶŽĨŵĞƌŝĐĂΠ,ŽůĚŝŶŐƐ͘ůůƌŝŐŚƚƐƌĞƐĞƌǀĞĚ͘

Branding Update Regarding

For Internal Use Only: All ෽ LN 50947 ෽ English ෽ 23June2021 ෽ WLK

With the above as an explanation, here is an example.

Third digit, since the last sponsor

Welcome to Xcellerate® Lab

- Call early in the day to schedule your pickup.

US, Canada, and Puerto Rico (specimens sent to Indianapolis)

2021 2022 2023

01 January 01 January 01 January New Year’s Day

For sites in US and Canada

US, Canada, Puerto Rico 866-762-6209 (Toll Free)

 Please check kit expiration dates before using

Please do not collect specimens in expired

 A unique accession number is assigned to each kit

Do not interchange the tubes and/or requisition

Labeling samples with unique identifiers:

 Each container label is pre-printed with a barcode

Refer to your Web resupply form for delivery days.

OCCURRENCE Day -28 to Day 0 - - - - Day 1 (± 2 days) - Day 2 (± 2 days)

English_Visit Test Schedule_Update: 20220122 ŽƉǇƌŝŐŚƚΞϮϬϮϭ>ĂďŽƌĂƚŽƌǇŽƌƉŽƌĂƟŽŶŽĨŵĞƌŝĐĂΠ,ŽůĚŝŶŐƐ͘ůůƌŝŐŚƚƐƌĞƐĞƌǀĞĚ͘

English_Visit Test Schedule_Update: 20220122 ŽƉǇƌŝŐŚƚΞϮϬϮϭ>ĂďŽƌĂƚŽƌǇŽƌƉŽƌĂƟŽŶŽĨŵĞƌŝĐĂΠ,ŽůĚŝŶŐƐ͘ůůƌŝŐŚƚƐƌĞƐĞƌǀĞĚ͘

SPECIALTY VISIT DEFINITIONS:

Kit - MANDATORY FFPE BLOCK

Kit - MANDATORY FFPE SLIDES 1-5 (IHC)

Kit - MANDATORY FFPE SLIDES 6-30 (NGS)

Kit - Every 16 Weeks from D1C1

Kit - OPTIONAL TUMOUR BIOSPY

Kit - DISEASE PROGRESSION

Kit - CTC EPIC NA/LATAM

STUDY SPECIFIC NOTES:

English_Visit Test Schedule_Update: 20220122 ŽƉǇƌŝŐŚƚΞϮϬϮϭ>ĂďŽƌĂƚŽƌǇŽƌƉŽƌĂƟŽŶŽĨŵĞƌŝĐĂΠ,ŽůĚŝŶŐƐ͘ůůƌŝŐŚƚƐƌĞƐĞƌǀĞĚ͘

TESTS VISITS COLLECT RETURN

AZD5363 PK 1HR POST Cycle 1 Day 2 1 x 2.0 mL lavender top 1 x cryovial

TESTS VISITS COLLECT RETURN

TESTS VISITS COLLECT RETURN

TESTS VISITS COLLECT / RETURN

TESTS VISITS COLLECT / RETURN

TESTS VISITS COLLECT / RETURN

TESTS VISITS COLLECT / RETURN

Cycle 1 Day 12,

BIOPSY/ TUMOR BIOPSY BLOCK

TESTS VISITS COLLECT / RETURN

TESTS VISITS COLLECT / RETURN

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TESTS VISITS COLLECT / RETURN

TESTS VISITS COLLECT / RETURN

TESTS VISITS COLLECT / RETURN

TESTS VISITS COLLECT / RETURN

Nomograph for calculating the centrifuge speed:

Using the RCF Nomograph

rotating radius. The point at which

the straightedge intersects the RCF B

SPEED - REVOLUTIONS PER MINUTE

For example, if the rotating radius is

ROTATING RADIUS ROTATING RADIUS

Recommended Order of Draw for Tube Collections

Draw Last Fluoride (Glucose) Tube

INSTRUCTIONS FOR USE:

IMPORTANT SAFETY TIPS

Any errors or missing details with regard to patient demographics will

Accession No. THE ACCESSION NUMBER IS THE

English_TableOfContents_Update: 20220122 ŽƉǇƌŝŐŚƚΞϮϬϮϭ>ĂďŽƌĂƚŽƌǇŽƌƉŽƌĂƟŽŶŽĨŵĞƌŝĐĂΠ,ŽůĚŝŶŐƐ͘ůůƌŝŐŚƚƐƌĞƐĞƌǀĞĚ͘

Please check kit expiration dates before using

A unique accession number is assigned to each kit

Each container label is pre-printed with a barcode

English_Visit Test Schedule_Update: 20220122 ŽƉǇƌŝŐŚƚΞϮϬϮϭ>ĂďŽƌĂƚŽƌǇŽƌƉŽƌĂƟŽŶŽĨŵĞƌŝĐĂΠ,ŽůĚŝŶŐƐ͘ůůƌŝŐŚƚƐƌĞƐĞƌǀĞĚ͘

English_Visit Test Schedule_Update: 20220122 ŽƉǇƌŝŐŚƚΞϮϬϮϭ>ĂďŽƌĂƚŽƌǇŽƌƉŽƌĂƟŽŶŽĨŵĞƌŝĐĂΠ,ŽůĚŝŶŐƐ͘ůůƌŝŐŚƚƐƌĞƐĞƌǀĞĚ͘

English_Visit Test Schedule_Update: 20220122 ŽƉǇƌŝŐŚƚΞϮϬϮϭ>ĂďŽƌĂƚŽƌǇŽƌƉŽƌĂƟŽŶŽĨŵĞƌŝĐĂΠ,ŽůĚŝŶŐƐ͘ůůƌŝŐŚƚƐƌĞƐĞƌǀĞĚ͘

^DϬϵͬZ,ͬEt&&W>K< DĂŶĚĂƚŽƌǇ&&WůŽĐŬ TO: LABCORP CLS