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DNA Collection

Handbook

800-523-6487 phone
206-219-4000 fax

www.genelex.com

Genelex Corporation
3000 First Avenue
Suite One
Seattle, WA 98121
TABLE OF CONTENTS

♦ Introduction

♦ Specimen Collection Procedures and Forms

♦ Shipping Instructions

♦ Genelex Paternity Services Information

♦ Welcome to Genelex

♦ Paternity Testing – Questions and Answers

♦ What is DNA Paternity Testing

♦ Parentage Test Request Form

♦ DNA in Parentage Testing, Excerpt From DNA In The Courtroom

♦ How To Read A Paternity Testing Report

♦ American Association of Blood Banks Accreditation

♦ Information on our other DNA Testing Services

♦ Supply Order Form


Genelex is pleased to have you as one of our independent DNA collection specialists. We are happy to
be able to refer our patients to someone who upholds our high standards of professionalism and
integrity. This handbook gives detailed directions on filling out the forms, packaging samples, and
shipping. In addition, you should view the Legal Paternity Test Sample Collection Demo at:
http://www.genelex.com/paternitytesting/Demo/Legal%20Collection/Legal_Collection_viewlet_swf.html

If you find that you have any questions about any of the procedures, please call us.

Our staff will provide you with well informed clients who have an expectation of the procedure at the
appointment. We will also advise them of the collection fee charged by you, as well as what form you
prefer to be paid in. Taxes are not withheld from this compensation and are your responsibility. Please
obtain your employers consent, if applicable.

It is expected that you will provide your own gloves. Genelex will provide, on your request, additional
collection kits, shipping materials, fingerprinting supplies. You are expected to provide Polaroid film or
printouts from your digital camera. (Please see enclosed supply order form.) You may also call our
receptionist for verbal supply orders.

In our experience, mobile collections for paternity testing work best if you contact the patient to arrange
the draw as soon as possible after we give you the information. It is also helpful, if you arrange the
appointment ahead of time, to call the patient to confirm just before you leave. Always carry picture
identification with you.

Please be sure to check the identification of adults you collect samples from. The identity of all
parties must be verified with a photograph on the “Identification/Custody Sheet”. Fingerprints
are no longer accepted forms of I. D. Before you leave the appointment, check all the paperwork over
to make sure you and the client have filled in and signed everything. Seal the samples and paperwork
in front of the patient.

Genelex is an internationally recognized leader in DNA analysis and has played a key role in the
invention and development of technologies used in paternity testing laboratories worldwide. We have
more genetic markers available for analysis than any other testing lab. Genelex is accredited by the
American Association of Blood Banks. We are committed to the highest level of quality assurance.
Welcome!
GENELEX PATERNITY SERVICES

Genelex is an internationally recognized leader in DNA analysis and has played a major role in the
invention and development of technologies in use in identity testing laboratories throughout the world.
Genelex is accredited by the American Association of Blood Banks and has been performing paternity
testing since 1987. Testing is done at our laboratory in Seattle, Washington, USA.

Genelex is committed to being the only choice for paternity testing worldwide. Genelex performs
paternity testing worldwide and is equipped with an extensive network of DNA collection facilities.
Genelex also employs several mobile DNA collection specialists in every major city nationwide
allowing us to offer several sample collection options. We also offer our clients a variety of payment
options. No other laboratory can match our commitment to making legally defensible DNA paternity
testing as convenient, affordable and accurate.

DNA TESTING

DNA testing is performed on blood or cheek cell samples collected from the child and tested man; the
mother's sample is useful but not required.. The identification of each participant and sample is
carefully documented.

A child receives half of his genetic profile from each parent. A series of tests on the genetic material
from the child and parents can exclude a man from consideration as the father. The same test can give a
high degree of certainty that the man is the father.

LEGALLY DEFENSIBLE TESTING


A strict chain of custody is maintained throughout the testing process. From the time the samples are
collected they are accessioned, tested, and cross-checked. They are then verified and notarized prior to
release ensuring legally defensible results.
SPECIMEN COLLECTION PROCEDURES AND FORMS

At Genelex we recognize how important our network of DNA collection specialists and
medical technicians are to the paternity testing process. With this in mind we offer the
following section specifically for the DNA collection specialists and medical technicians
collecting samples for our DNA paternity testing clients.

The standard identification form most commonly used is the “Identification/


Custody Sheet”. Please carefully look at the examples of this form provided in this
handbook. For each case you collect samples for Genelex will require this form to be
filled out and signed. While these forms are easy to complete they are vitally important
to the case. These forms maintain a strict Chain of Custody assuring the client legally
defensible results.

In this section of the handbook you will also learn how to record necessary information
for sample collections. Please refer to the drawsite checklist when doing a sample
collection so you can confirm that all of the required steps have been taken.

Thank you for taking the time to review the information provided in this section and
please contact Genelex with any questions or concerns you may have.
SHIPPING INSTRUCTIONS

Genelex pays for all shipping costs as long as you send samples via 2nd day delivery, not
overnight (unless prearranged with a Genelex representative). Our primary shipping
carrier is DHL. Genelex will furnish addressed airbills and shipping packs. If you are
not able to use DHL due to your location or any other factor, please contact our
receptionist for assistance. We also can use FedEx.
Accuracy and reliability in the preparation of all
legal DNA Testing Documentation is of critical
importance to Genelex’s process and to the proper
discharge of our our legal and reporting obligations.
You must never misrespresent facts or falsify any
information during the the DNA sample collection
Process. Failure to comply may be punishable by
law.
LEGAL RELATIONSHIP TESTING SPECIMEN COLLECTION INSTRUCTIONS
The kit you receive will contain the appropriate materials and paperwork for sample collection.
Drawsites: Wear gloves and follow appropriate biohazard collection procedures.
Buccal Cheek • Collect, label, and package swabs from one individual at a time.
Swabs
• Have the client rinse the inside of the mouth with drinking water.
• Remove a sterile swab from the appropriate envelope
Pink for Mother, yellow for Child-(including adult children in kinship tests); blue for Tested Man.
• Rub the inside of one check vigorously; 25 times per swab while rotating swab.
• Air dry swab in an upright position for at least 10 minutes (place in a clean empty glass or clean coffee cup with
the cotton tip of the swab pointed up as in the diagram below).
• Collect 4 swabs per person (2 per cheek). Note: for kinship testing, 8 swabs will be needed per person (4 per
cheek). For Ancestry testing only 2 swabs are needed
• Write the name of the person just collected on the swab label. Wrap the label around the swabs in a flag-like
manner, place dried swabs into the envelope provided and seal.
Do not lick the envelope.
• Initial the envelope and label with the client’s name and date. Have the client initial the label.
• Collect swabs from the next individual by repeating the above steps.
• Ship samples the same day. Store samples at room temperature if held overnight or over the weekend.

Blood • Collect one yellow or purple-topped vacutainer tube per person. Minimum is 1ml.
FTA • Remove one FTA Micro-Card paper from the plastic bag and write the appropriate name on the line provided. DO
MicroCard NOT touch the part of the card in the circle.

• Prick the finger of the client with the enclosed lancet and apply the blood to the circle on the FTA MicroCard.
Once collection is complete place the FTA Micro-Card paper back in the plastic bag and place the appropriate
label on the outside of the plastic bag.
Cord Blood • For a newborn, collect one tube of cord blood from the baby. Minimum is 1ml.
CVS • Collect biopsy and send to cell culturing lab. Once cultured, mail to Genelex.
Prenatal cells • Collect two T25 flasks of confluent cultured cells. Compete specimen collection and chain of custody portion of
paperwork.
Amniotic • Collect 3-8 ml amniotic fluid into the provided 15 ml sterile plastic tube.
Fluid
Abortus • Place “Collection Sock” into the provided 50 ml sterile plastic tube. Tissue from an older abortus shall be selected
by the physician and an approximate 2 cm2 portion placed into the tube.
• Specimens will be disposed of one year from test completion unless Genelex is otherwise notified in writing.
Hair • Place 5-10 pulled hairs (include hair root) into provided sterile plastic tube.

Human • Place an approximately 2 cm2 piece of tissue into the provided 50 ml sterile plastic tube. Muscle tissue is preferred,
Tissue call for details if this is not available.

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DNA RELATIONSHIP TESTING
LEGAL SPECIMEN COLLECTION CHECKLIST
PLEASE PRINT ALL INFORMATION LEGIBLY
TO BE COMPLETED BY THE CLIENT

Identification Sheet (box area): Fill in the name for each tested adult, even if their specimen is being
collected at another time. Fill in the race, birth date and medical information for the tested parties.
Identification Information: Fill out the address, phone number, driver’s license and SSN number for each
adult from whom a specimen is currently being collected. Show ID to person collecting specimens. Be
sure to write in the email/fax for each adult if you want results also sent electronically.
Authorized representative: If you want this test to be discussed with any non-tested individual such as an
attorney, fill out his or her name, address and phone number under the Identification Information section.
If no persons are noted here, we will not discuss this test with anyone that is not being tested.
Statement of consent and release: All tested adults must sign (no reports will be released without this
consent). If a child is under 18, their legal guardian must sign for them.
Photograph: Each tested adult must sign and date the photograph or copy of government identification.
Take a picture of each tested child. An authorized adult must sign for children's ID.
Specimen collection: Each tested adult must sign the specimen label on the envelope to verify the
information and collection. An authorized adult must sign for child’s specimen.
TO BE COMPLETED BY THE PERSON COLLECTING THE SAMPLES

Identification Sheet: Fill in your name, agency address, phone number and the date the specimens were
collected at the top of the form.
Identification Sheet (box area): Sign for each person from whom a specimen was collected.
Identification Information: Verify the clients’ ID (driver’s license, SSN number, birth certificate or other
government issued photo ID).
Photograph: Take a Polaroid and/or a legible copy of government issued photo identification (such as a
driver’s license) of each individual including the child at the time of collection and attach it to the back of
the form where indicated. A photograph of all tested individuals, as fingerprints are no longer accepted
forms of ID, should be placed in the appropriate box. Obtain the signature and date of each tested
individual on their photo, or photo ID.
Specimen collection: Collect the sample from one person at a time. Select the appropriate tube or
envelope. Print the name of the tested party, the date of the collection and your initials on each label and
immediately attach the label after collecting the specimen. Hand the collected sample to the test
participant or person providing legal consent and have them initial on the labels and envelope.
Chain of Custody: On the identification sheet, verify by signing that you sealed the kit and include the
carrier service and date sent to Genelex.
If there is a witness in addition to the sample collector, have him or her include name, signature, contact
address, and phone number at the top of the form.
Package samples into the return envelope, enclose paperwork and close the tamper-proof seal on the flap.
Seal kit into courier package provided and ship immediately to:
Genelex Corporation
3000 First Ave., Suite 1, Seattle, WA 98121
1-800-523-6487
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The Following chain of custody form is an example so you can examine our paperwork

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DNA PATERNITY TEST Page 1 of 2
LEGAL IDENTIFICATION SHEET
Person Collecting Samples: Agency (if applicable):
Address: Date of Draw: _______
City, State, Zip: Phone:
Name of Witness (optional): Signature:
Address: Agency (if applicable): _______
City, State, Zip: Phone:
NAMES OF ALL PERSONS BEING RACE BIRTH- SEX MEDICAL SPECIMENS COLLECTED BY:
See DATE (M Had a bone Sign for each person from whom a specimen was
TESTED options or marrow transplant collected
Include individuals from whom specimens below F) or a blood
transfusion within
will be drawn at another time. the past 3 months?

Mother: Yes No

Child #1: Yes No

Child #2: Yes No

Tested Man: Yes No

Other: Yes No
Indicate predominant racial group (one only): C: Caucasian A: Asian AB: African American H: Hispanic NA: Native American
SEND RESULTS TO (Note: All tested adults or signing guardians are legally entitled to a copy.)
Name: Name:
Address: Address: _______
City, State, Zip: City, State, Zip:
Phone: Phone:
E-mail or Fax: E-mail or Fax:

I authorize Genelex to discuss testing with the PHOTO ID


following non-tested individual: Attach Photograph and/or copy of
Is this person your attorney? Yes No Government photo identification of all tested parties
Does this person need a copy of the results? Yes No to the back of the form.
Sign and date photo ID.
Name:
Address: CHAIN OF CUSTODY
City, State, Zip: Date Sent to Genelex: Carrier Service:
Phone: Carrier Tracking #:
E-mail or Fax: Kit sealed by (print, please):
STATEMENT OF CONSENT & RELEASE (Payment and signature(s) must be received before results are released)
I hereby certify that the information provided is true and accurate and that I have legal authority to order this testing. I consent to the collection of specimens from myself and the
listed child(ren) for the purpose of parentage testing. I grant Genelex Corporation permission to release the results to all adults and their duly designated representatives. Genelex
reserves the right to re-collect samples for retesting and to store samples for future additional tests, if necessary. Genelex Corporation’s limit of liability is not to exceed the cost of
the testing. This agreement for testing is subject to and shall be construed and enforced in accordance with the laws of the State of Washington. The parties agree that the exclusive
jurisdiction and venue for any dispute or controversy arising from this agreement shall be in the State or Federal courts in the State of Washington. I understand that while
parentage testing is highly accurate and widely accepted, as in all testing there is a possibility of delay and/or error. By signing this release, I understand that I/We will be held
responsible for payment of testing fees, including any necessary cost of collection and reasonable attorney fees. I allow Genelex to release customer data to outside third parties to
assist in the collection of any unpaid fees. Testing fees are not refundable after testing has started or after 180 days from order date.

Signature of Mother Signature of Tested Man Signature of Child- If under18, Legal Guardian must
sign

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DNA PATERNITY TEST # Page 2 of 2
LEGAL IDENTIFICATION SHEET

MOTHER TESTED MAN

Staple photo of Mother above. Staple photo of Tested Man above.


If photo unavailable, place legal ID above. If photo unavailable, place legal ID above.

Date: Date:

Driver’s License or SSN #: Driver’s License or SSN #:

Signature of Mother Signature of Tested Man

Signature of Specimen Collector Signature of Specimen Collector

CHILD # 1 CHILD # 2

Staple photo of Child # 1 above. Staple photo of Child # 2 above.


If photo unavailable, place legal picture ID If photo unavailable, place legal picture ID
above. above.

Date: Date:

Signature of Child #1- If under 18 Legal Guardian must sign. Signature of Child #2- If under 18 Legal Guardian must sign here.

Signature of Specimen Collector Signature of Specimen Collector

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Copyright © Genelex Corporation - Seattle, WA . All rights reserved.
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A parentage test lasts a lifetime and profoundly affects our clients' lives. We proudly accept this responsibility
because we have the best people, experience, and facilities available. At Genelex, we are committed to perform the
most accurate DNA test possible and provide superior service through every step of the testing process. Our DNA
Testing Consultants work side-by-side with our lab personnel to ensure that each case receives our utmost care and
attention. Since 1987, Genelex has been repeatedly recognized for our commitment to excellence. If you, or one of
your clients or friends have questions about parentage testing, call 800 TEST-DNA with confidence. Here's why:

Top Rated by agencies, customers, and the media.


• More than 99% of Genelex customers respond positively to our regular follow-up surveys. Read
what they have to say on our web site www.genelex.com.
• Oprah Winfrey, CNN, and many other media sources choose Genelex when looking for experts
to explain DNA testing and comment on cases in the news.
• Top 10% of AABB accredited parentage testing labs in accuracy and turnaround time.
• Rated in the 90th percentile or above by the Dun & Bradstreet Past Performance Survey in cost,
timeliness, customer support and overall reliability and quality.
Accuracy, Service, Flexibility, and Experience.
• Higher Accuracy. Genelex tests are 100 times more discriminating than the industry
standards, meeting or exceeding all state, federal, or international legal requirements. We
surpass even stringent FBI testing standards by testing 20% more genetic data than FBI
crime labs. We test 16 markers vs. the 8 to 10 tested in most labs and verify the sex of all tested
individuals to assure you of reliable results. Additionally, if the tested man is found not to be the
father, we rerun the entire test to confirm the exclusion.

• Better Customer Service Genelex DNA Testing Consultants walk clients through every
step of the DNA testing process, providing results in an average of four-to-six days. This
commitment to service earned a Dun and Bradstreet rating of 94% in customer support and
responsiveness.

• Greater Flexibility Genelex provides the broadest spectrum of testing options available
anywhere including legal and in-home testing, worldwide sample collections, and testing of
extended family relationships. We are constantly improving client options and upgrading
technology to remain at the forefront of the industry.

• More Experience A pioneer in the industry, Genelex has been providing DNA testing
since 1987. Our testing has held up under intense scrutiny including Supreme Court Review and
was key to the settlement of the $800,000,000 Larry Hillblom estate.
Founded in 1987, Genelex Corporation is accredited by the American Association of Blood Banks (AABB)Parentage Testing
Committee in DNA parentage testing since 1992 and is Washington State Medical Test Site No. MTS-3919 CLIA No.
50D0980559. Genelex was accredited by the American Society of Crime Laboratory Directors Laboratory Accreditation Board
(ASCLD LAB) in forensic DNA testing from 1998-2003 and has contributed to the validation of National Institute of
Standards and Technology (NIST) Standard Reference Materials.

For immediate consultation Call 800-TEST-DNA (800-837-8362)


Hours 7:00 AM to 6:00 PM PST, 10:00 AM to 9:00 PM EST, fax 425-825-1870,
e-mail: info@genelex.com Web: www.genelex.com
Se habla español.
Paternity Testing
Questions and Answers

How Accurate is DNA Reports are mailed to all tested What other types of parentage
Testing? adults and their designated testing do you offer?
DNA Testing is the most accurate representatives. Reports can be sent
technology available for determining by fax or e-mail if requested, but Genelex routinely performs the
paternity and other family not by telephone. The report is a broadest spectrum of identity tests
relationships. Genelex’s testing proves confidential notarized legal available today. This allows us to
or disproves paternity in all cases. document that has a scientific report results with a high level of
Each report states clearly that: description of the genetic patterns certainty even when key family
determined for each individual. members are unavailable.
• The tested man is excluded and We also include information that • Pre-Natal testing is performed on
cannot be the biological explains the test results in everyday samples obtained by trained medical
father. language. personnel using the amniocentesis or
CVS (chorionic villis sampling)
OR How do I pay for the test? procedures. It is the responsibility of
• The statistics in the report Payment for testing can be made by the client to seek medical advice
prove that he is the cash, money order, Visa, MC, AMEX, concerning the performance of these
biological father. or DISC. Do not send cash with procedures.
collection kits. Results will not be • Grand Paternity is ordered when
How can I schedule Testing? released until full payment has been the father is unavailable. It is a
Just call your Genelex DNA Testing received. Contact your DNA testing straightforward test when both of his
Consultant who will customize the consultant about the availability of parents are available for testing and his
arrangements for you whether you need payment plans. paternity is not in question.
LEGAL or IN-HOME TESTING. • Kinship Analysis is more
Specimen collection fees for legal tests Is the mother always tested?
No, but if the mother is tested, the test complex because relationships must be
are paid directly to the collection agent determined using fewer and more
or facility unless other arrangements may take less time and will provide for
a higher level of statistical certainty. distantly related individuals, such as
have been made. Please have your the child’s Aunts and Uncles or
photo ID with you at the time of When the mother participates we are
able to subtract her contribution to the Brothers and Sisters. It is possible
collection. using the most advanced testing
child’s DNA pattern before comparison
methods to determine if two people are
What about confidentiality? to the tested man’s.
siblings, half-siblings or unrelated.
Information of any kind regarding a
case will not be released to anyone Does the child have to be a • Deceased individuals can be
other than the tested parties and their certain age to have a DNA tested using medical, funerary, or
named representatives without written test? abandoned materials. These cases are
authorization. All records are stored in No. We regularly test newborn infants often routine or they may involve
a secure facility. using umbilical cord blood, an easy serious criminal charges and difficult-
procedure that takes place right in the to-work-with samples. We have
How long does the test take? delivery room. For other young extensive experience and an
Reports are provided five to seven children we use cheek (buccal) swabs. outstanding, courtroom proven record
business days following receipt of all In all cases, the test is painless. with these cases. If the date of death is
samples. RUSH TESTING in one day recent, CALL IMMEDIATELY.
or three days can be ordered. Call now Do I need a Doctor’s or
for details. Lawyer’s order? Who is Genelex?
No. Unless you live in the state of Started in 1987, Genelex is an
What if the tested parties New York, Genelex must either internationally recognized pioneer in
live in different cities? receive a court order or doctor’s paternity testing and DNA analysis.
Must they go in together? prescription to perform the DNA Included in our more than 100,000
No. We have a worldwide network of test. Most of our clients order and cases is a Supreme Court review of a
collection centers. In many locations schedule testing over the phone criminal paternity case. Our testing
medical personnel can come right to directly from their DNA Testing was also key to settlement of the
your home. You and your Genelex Consultant. If you want us to $800,000,000 Larry Hillblom estate.
DNA testing consultant will coordinate c o m m u n i c a t e w i t h a ny i n v o l v e d Although many of our cases are high
the timing and arrangements for all relatives, doctors, or attorneys you profile, we provide confidential testing
tested parties. must authorize us to do so. for regular Moms and Dads everyday.

How will I receive my test


results?

For immediate consultation Call 800-837-8362


Hours 7:00 AM to 6:00 PM PST, 10:00 AM to 9:00 PM EST, fax 206-219-4000,
3000 First Avenue, Suite One, Seattle, WA 98121
E-mail: info@genelex.com Web: www.genelex.com
©2007 Genelex Corporation
DNA IN PARENTAGE TESTING
UPDATED FOR THE WEB EDITION
April 2000
Introduction to Parentage Testing

In the United States, establishing paternity has become a major industry. Government efforts to recover
child support funds bring in over five billion dollars a year at a cost of one-and-a-half billion dollars.
State and local child support agencies, working under Title IVD of the federal Social Security Act, Aid
to Families with Dependent Children, administer these programs for the benefit of unsupported children.
This statute requires that when a woman obtains public assistance for her children, she MUST name the
possible fathers. These programs generate the bulk of more than 220,000 paternity tests performed
annually. In a country where 30% of births are to single mothers, and 15% of fathers of record are not
the biological father, the large number of tests is not surprising.
Parentage testing cases are numerically the largest user of DNA testing. More than 200,000 of the
paternity tests performed in the United States every year use DNA testing exclusively or as a supplement
to conventional blood testing. HLA (Human Leukocyte Antigen) and other classical blood typing tests
often can resolve a routine paternity case without resorting to DNA testing. The HLA blood types are
the types that must be matched before an organ transplant, such as bone marrow, kidney or heart, can
succeed. Limitations of conventional blood testing are that the blood must be fresh when tested, and
only a limited amount of genetic information is obtainable. Also non-blood cell types, such as those
found in semen, do not have an HLA and most other common blood types, rendering this type of testing
much less useful in forensic cases. The advantage of DNA testing is that many more variable genes, up
to thirty or more, are available. In effect, our ability to do paternity testing is no longer limited by the
amount of genetic information that we are able to obtain.
Most paternity testing is done for financial reasons, i.e., to establish legal responsibility and provide for
child support. Even more important are the emotional and social issues. When testing can demonstrate
conclusively to a man that he is the father of a child, then he is more likely to provide not only financial
support, but emotional support as well. He may bond with the child and take an active part in its life.
The importance of establishing paternity early is nowhere more clearly shown than in the testing of adult
children, some of whom are in middle age. "Who is my father?" is a question that may have haunted
them their entire lives.
It wasn't very long ago that obtaining a paternity test was an uncertain, expensive and inconvenient
process. It was hard to find a place to have the blood drawn to initiate the testing and redraws were
common as the blood had to reach the laboratory in one or two days. A doctor's or a lawyer's
involvement might have been required, and, even after the effort and expense, the results often came
back with a considerable degree of uncertainty. Also, there were no inspection and certification
programs available to parentage testing laboratories which provide an assurance of quality.
DNA testing has made the process convenient and the results conclusive. The testing is still expensive
and takes a week or two to complete, but anyone can order it. In all but the rarest of instances, the DNA
test results provide a level of certainty so high that paternity will, for all practical purposes, be proven or
disproved.
One of the greatest benefits DNA has brought to parentage testing is the ability to solve many more
types of cases. In the usual case, tests include all three parties, i.e., the mother, child and alleged father.
With DNA, it is not necessary to have the mother's sample in order to provide a conclusive test result. It
is possible to distinguish between two brothers provided they are not identical twins. In many cases, it is
possible to perform the DNA tests when the alleged father is deceased or otherwise unavailable. It also
is possible, using DNA, to perform testing before or at the time of birth. Tests also can be performed on
some very unusual samples such as envelope flaps, cigarette butts, and very old blood stains.

What Happens at the Sample Collection


Throughout this country, and the entire world, is a network of individuals licensed and experienced in
the legal sample collections that are necessary in paternity testing. These collections differ from medical
collections by the extent to which they are documented. Clients who are being tested for paternity will
be asked to show a picture ID, fill out and sign release forms and identification labels, and a photo will
be taken. In this way the chain of custody (COC) that must be maintained throughout the transport and
testing can be assured. In order for the COC to have maximum integrity the tested parties should not be
involved in the shipping or handling of the transport kit. It should be sent directly to the collection site or
personal physician, and include pre-addressed return airbills with instructions.

*Only a small volume of blood, a teaspoon or less, will be taken in a draw. Children, even babies, usually tolerate it quite
well. The blood samples from babies also are drawn from the arm because it is less painful and much quicker than a heel or
finger stick. Unlike former practices, blood now can be drawn any day of the week, and all parties need not be drawn at the
same time or place.

Buccal or Cheek Swabs and Home DNA Paternity Tests


*Over 99.9% of all of our collections now are performed using a "buccal swab," a device
that resembles a Q-tip (however the material on the tip of the swab is made of a
specialized material designed to collect the epithelial cells from the inside of a person’s
cheek.) This type of collection has made the "home paternity DNA test" possible. The
home test is the ultimate in convenience. Unfortunately, it has minimal legal standing
because it is generally impossible to independently verify the identity of the individuals
who have been tested. There is no chain of custody. Another type of home DNA test
overcomes these obstacles because the collection is performed in home by a medical
professional who comes to the home. This level of service is not available everywhere
but is becoming more available all the time.

PARENTAGE TESTING APPLICATIONS

Prenatal and Newborn Paternity Testing


Formerly, it was impossible to test babies until they were six months old. Testing blood from the
umbilical cord of a newborn now is one of the most convenient and effective ways to obtain a paternity
test. At the time of birth labor and delivery staff will take blood from the umbilical cord after the baby is
born, collect from the mother and ship the samples to the laboratory. Arrangements must be made in
advance and if the alleged father has been drawn prior to the birth, testing can start immediately.
One of the fastest growing areas DNA paternity tests is prenatal testing. While it has been possible for
many years to perform a prenatal test for paternity, it has not been routinely done because of the small
risk to the fetus and the long turn around time (six to eight weeks.) That is changing as the
amniocentesis and chorionic villus sampling procedures become more accepted and routine. These are
the procedures for obtaining cells from the unborn baby which, in the past, have been limited to women
over thirty-five or for families with a history of genetic disease. With the latest in DNA testing methods
results can be obtained in a matter of days.

Deceased Alleged Father


This type of DNA testing often is needed to obtain Social Security or insurance benefits, to settle an
inheritance dispute or to establish standing in a wrongful death action. There are two basic approaches to
solving these cases. The first is to obtain a postmortem sample of the father's DNA. The second is to
reconstruct his genotype based on surviving family members. Samples from the deceased may be
obtained from the medical examiner, coroner or other pathologist who may have performed an autopsy,
an associated toxicology or medical lab, the funeral home before or after embalming, or even following
burial for up to several years.

Kinship Analysis - Missing Alleged Father


If samples from the deceased are not readily available then the alleged father's genotype can be
reconstructed by testing close relatives. The most straightforward of these tests is a grandpaternity test in
which the alleged father's parents are tested. If one or both of his parents are missing, then samples from
his siblings or other children can be used and extended typing performed. Any combination of three or
four of these close relatives will result in a highly conclusive test. When fewer relatives are available for
testing, the ability to provide a conclusive result decreases. Relatives farther removed from the alleged
father such as cousins are not related closely enough to provide useful information. One caution to this
type of testing is that if the relationships are misrepresented to the laboratory, a false negative may
result.

Sibship Analysis
The most difficult kinship analysis is to determine if two individuals are full or half siblings when those
individuals are the only ones available for DNA testing. If the number of tested siblings increases or
other relatives become available, the degree of certainty increases dramatically. It also is easier to
determine if two individuals are full siblings or completely unrelated. Advanced genetic methods and
specialized computer programs are required to reliably solve these cases. It may be necessary to test
twelve or fifteen or more genes in order to make a determination.

Criminal Paternity
The most common and most disturbing criminal paternity cases are those involving the sexual abuse of a
child. Laboratory testing is not possible in many of these cases because the abuser is a relative or close
friend of the family, and the crime comes to light after the physical evidence is gone. Sometimes these
unlawful sexual contacts do result in a pregnancy, especially if they continue over an extended period of
time. In this instance, the DNA testing is usually routine and can be performed on the child or an abortus
that is older than six weeks. DNA testing may be especially useful if there are closely related suspects,
such as a father and son or two brothers. Criminal cases also may require the application of non-routine
statistical and reporting techniques depending on the requirements of the court.
Cases where the victim of sexual abuse is underage rarely go to court. The offender usually will receive
a lower prison term if he pleads guilty. Conviction in the face of DNA evidence is almost inevitable. In
cases where the victim is an adult and consent is a defense, the defendant may change his story when he
realizes that the DNA testing results are almost impossible to refute. The jury is usually unaware of this
change of story and so often will vote to acquit the defendant.
DNA parentage testing has been questioned by the courts in only a handful of cases. Typically, less than
1 or 2 percent of civil cases result in a case contested in trial. The opportunity to have testing repeated
by the same or another laboratory usually can settle most disputes to the satisfaction of all tested parties.
In criminal cases, when the testing is scrutinized extensively in court, it is almost universally accepted.
Genetic Reconstruction or Reverse Paternity
These techniques often are used in homicide investigations. Suppose that there is a tissue sample from
an unidentified deceased individual, or a stain from a crime scene and investigators have an idea of who
may be the sample's source. If the decedent's parents or children are available, it will be possible to
compare the related survivors' DNA profiles with that of the deceased to conclusively determine whom
the remains came from.

Test Results
Paternity testing is possible because everyone has two copies of their genetic information, half from
each of the parents. If a child has a gene that didn't come from the mother, then it must have come from
that child's biological father. If the alleged father does not have that gene, the obligate gene as it is
called, then he cannot possibly be the father. He is excluded from the group of men who could be the
father of the child. There is one exception. If a mutation has occurred, which means the gene changed
when it was passed from the father to the child. These mutations rarely occur, but they occur often
enough that statistical methods are available for dealing with them and two DNA exclusions are required
before reporting out a DNA paternity test result.
The other possible outcome is that the alleged father has the obligate gene and so is included in the
group of men who could be the father of the child. In effect, what paternity testing does is examine a
series of genes until the group of men who could be the father of the child is narrowed down to the point
that we can, for all practical purposes, be certain that he is the father. In DNA testing, this can be
accomplished by testing as few as three highly variable genes.
Two different ways are used to report the two possible testing outcomes. An exclusion is reported as a
simple statement that the alleged father is excluded from the group of men who could be the father. In
the case of an inclusion, a statistical analysis is performed based on how common or rare are the obligate
genes. These are the genes that the alleged father could have contributed to the child and that must have
come from the child's biological father. The inclusionary results are expressed in the following two
ways:

The Paternity Index


The first is the paternity index (PI), which is a simple odds ratio. Because of the increased accuracy
possible with DNA testing, the generally accepted minimum standard for an inclusionary result has risen
to a PI of 100. This means that the alleged father has a 99 to 1 better chance of being the father than a
random man. It does not mean that the test is only 99 percent accurate. A more realistic way to look at
this result is to consider that the alleged father has a PI of 100 and that the genetic profile he must donate
is found in approximately 1 in 100 randomly chosen men. If he has been falsely accused, then he has the
required 1 in 100 profile. The probability of these two events occurring together is more realistically
thought of as 1 in 10,000.
DNA test results typically produce odds ratios of hundreds or thousands to one. As a practical matter,
once a PI of 100 is reached, the probability of overturning that result with further testing becomes
extremely small. In practice, the test results are reported out according to the race of the alleged father.
While the results can vary slightly from race to race, as a practical matter, when modern DNA testing
methods are used, the race of the father doesn't make a significant difference.

Probability of Paternity
In the second way, the probability of paternity is calculated simply by converting the PI to a percentage.
However, it can be the most confusing because the equation that is used for the calculation contains a
term called the "prior probability." This term takes into account the non-genetic factors that would have
a bearing on paternity. In the laboratory a neutral value of 0.5 is universally used. It favors neither the
alleged father nor the mother.
The paternity index and probability of paternity represent a comparison of the alleged father against a
random man in the population. If there is a close relative who also could be the father he also should be
tested. If he is unavailable, then the laboratory can take that fact into account when doing the testing and
calculations.

Choosing a Laboratory

Because paternity laboratory inspection is not mandatory, there is a wide range of quality among the
laboratories. On the fringe are a number of small laboratories which do a low volume of testing and do
not subscribe to the established quality control assurance programs. In evaluating a parentage testing
laboratory, one should ask if it is accredited in DNA testing by the American Association of Blood
Banks. Labs may be accredited in the older types of testing, such as HLA and red blood cell testing, but
not in DNA testing.
When contacting a laboratory, if it is not possible to talk with an understanding, helpful and
knowledgeable client services representative, it might be advisable to look elsewhere. A lab may do fine
work, but if there is not someone available to clearly explain the process and results, it can be
frustrating. Another factor which can help in laboratory selection is whether or not the laboratory has
provided testing and testimony in criminal cases, which require the most advanced expertise.

Important Information for Relationship Tests Needed for Legal purposes

The American Association of Blood Banks [AABB] is the accrediting agency that has installed stringent
requirements in procedures protocols, and standards for DNA parentage, kinship and relationship
testing. Just go to www.aabb.org and on the left hand side navigation menu will be: Accreditation;
When you put your cursor over this it will change color to navy and give a list of drop down options,
then move your cusor a little left and down to Relationship Testing Accreditation Program, and click
on: AABB Accredited Parentage Testing Laboratories.

On this page you can check out the complete list of AABB Accredited Parentage Testing Laboratories.
Now you can tell if the DNA testing laboratory you plan to utilize for your DNA testing is on this list of
accredited facilities. If you don’t have internet access, the AABB can be contacted via mail at 8101
Glenbrook Road, Bethesda, MD 20814-2749, or you may call the AABB at 301-215-6584 to determine
if the DNA laboratory you plan to use for your DNA testing has passed their rigorous and precise
standards and are accredited by the AABB.
How to Read a Paternity Testing Report

CONCLUSIONS
A paternity test has two possible outcomes:
1. The tested man is the father. If the report says that the tested man cannot be excluded as the biological father of
the tested child, the results will be reported as a statistic known as the Combined Paternity Index. A Combined
Paternity Index of 100 or greater is the accepted standard to establish parental rights (sample report # 1).
2. The tested man is not the father. The report will say that the tested father cannot be the biological father
(excluded) of the tested child. The report will show a minimum of two inconsistent systems (sample report # 2).
Similarly, a maternity test will indicate whether the tested woman is or is not the biological mother of the tested
child. The tested person whose parentage is in question is called an alleged parent during testing.
GLOSSARY OF TECHNICAL TERMS
System. The specific laboratory DNA tests that were performed in this case. These DNA tests have been validated for
use in parentage testing laboratories.
Alleles. These DNA markers are the results of the specific laboratory DNA tests that were done in this case. Children
inherit one allele at each tested system from each parent. If only one allele is listed, the child inherited the same allele
from each parent.
Inconsistent. The result of a specific DNA test that is not consistent with parentage. For instance, at system D3S1358,
the child gets the allele 14 from the mother and therefore the 15 must come from the biological father. If the tested man
doesn’t have a 15 at this system, this is inconsistent with paternity. If 2 or more inconsistencies are found, the tested man
cannot be the biological father.

Mother Child Alleged Father


System Allele Allele Allele Allele Allele Allele
D3S1358 14 16 14 15 18 inconsistent

Excluded. The combined result of a Paternity test showing two or more inconsistencies. The tested man cannot be the
biological father of the child.
Paternity Index (PI). A required statistical value that compares the chance that the tested man passed the required
genetic marker to the child as compared to an untested, unrelated man of the same race. For instance, at system
D3S1358, if the child gets the allele 14 from the mother, the 15 must come from the biological father. This tested man
has a 15 which is consistent with paternity. A PI is calculated.

Mother Child Alleged Father


System Allele Allele Allele Allele Allele Allele PI
D3S1358 14 16 14 15 15 2.5506

Combined Paternity Index. A summary of the genetic evidence of a match between a tested man and a child. The
individual PI’s are multiplied to calculate the combined paternity index.
Probability of Paternity. A required statistic, based on the Combined Paternity Index, used to express the significance
of the test results. It is not possible for this value to reach 100%. A Probability of Paternity of 99.0% or greater is the
accepted standard to establish parental rights.
Prior Chance. A required part of the mathematical equation that is used to calculate the probability of paternity from the
Combined Paternity Index. The value of 50% is a neutral value and is the universally used standard. It means there are
only two possible outcomes, paternity or non-paternity.
American Association of Blood Banks, Parentage Testing Committee. The voluntary agency that develops standards,
inspects and provides accreditation to parentage testing laboratories.
For more information read “DNA in the Courtroom a Trial Watcher’s Guide” at www.genelex.com.

Copyright 2006 © Genelex Corporation, Seattle, WA.


All rights reserved. Updated 1/05, 05/06 TA, KA
Ancestry DNA Testing

Have you ever wondered about your ancestry?


Leading anthropologists have turned to DNA because they can learn about the past by studying the present in DNA from people
around the world. Now you can order the same DNA tests that have revolutionized the study of human history and embark on your
own personal expedition of genetic discovery.
The reports that come with your DNA tests explain what the results mean to you as an individual. What's more important, they're
written in language you can understand.

• Common Female Ancestor Testing (for males and females) examines DNA which is passed from mother to child (mtDNA-HVR-1). There are
33 major maternal clans or haplogroups in the world. Many maternal clans are continent specific and subdivisions are often regional specific.
All Europeans are descended from seven maternal clans as outlined in The Seven Daughters of Eve by DNA researcher Brian Sykes. Which are
you from? Do you have markers that are largely confined to specific areas of Europe, such as Sardinia or the Basque region.

• Common Male Ancestor Testing (for males only) will provide you with an analysis of 24 genetic markers that are passed from male
descendent to male descendent. These markers were selected because they remain identical for 20 generations or more. If your Common Male
Ancestor Test and another man's Common Male Ancestor Test are identical then you share a common male ancestor. Tests based on paternal
inheritance can place you in a specific ethnic group, or link you to surname groups that can put you in touch with potential living distant
relatives.

• Native American DNA Heritage Four maternal clans, each associated with a specific language group, dominate the ancestry of Native
Americans. Maternal line testing can discover if you have a female ancestor (your mother's, mother's, mother, etc.) from one of these groups.
Paternal Line Native American Test (Y-DNA for males only) examines DNA from the paternal line (your father's, father's, father, etc.) for
genetic markers unique to Native Americans. Possession of one of these markers is some of the best genetic evidence available for
demonstrating Native American Ancestry. Ethnicity testing described below may be useful if your Native American heritage is not inherited
from a direct maternal or paternal ancestor.

• Ethnicity DNA Testing (for males and females) will provide a global view of your overall genetic makeup. The test gives you an estimated
percentage of ancestry from the following groups:
• Africans (Sub-Saharan)
• European (Europeans, Middle Easterners and South Asians such as Indians)
• East Asians (Japanese, Chinese, Koreans, Pacific Islanders)
• Native American (those peoples that migrated to inhabit South and North America)

• European Ethnicity DNA Testing (for males and females) further refine your European ancestry if you have completed Ethnicity
DNA Testing and your results show over 50% European less than 15% Sub-Saharan African, less than 15% Native American, and less than 40%
East Asian. This service will predict your European heritage among the following groups:
• Northern European
• Mediterranean
• Middle Eastern
• South Asian

The process is simple. We will mail you a collection kit with cheek swabs to collect your DNA sample painlessly. Simply return the swabs to our lab
and we will perform the test and issue results about four-to-eight weeks later.

Start unraveling the mystery of your DNA and heritage today, call 877-431-4362 to place your order. Don't forget to ask about our other
informational genetic testing products now as you receive significant discounts when ordering tests at the same time.
DNA Prescription Drug Reaction Testing

"It's very hard for me to think about prescribing without it." - David Mrazek, Head of Psychiatry, Mayo Clinic

Reduce your risk of adverse drug reactions!


Research shows that of all the factors, such as age, sex, weight, general health and liver function that alter a
patient's response to drugs, genetic factors are the most important. This information becomes even more critical
when you consider that adverse reactions to prescription drugs are killing about 106,000 Americans each year --
roughly three times as many as are killed by automobiles. This makes prescription drugs the fourth leading killer in
the U.S., after heart disease, cancer, and stroke.
Many Drugs Affected
Approximately one-third of the 200 most commonly prescribed heart medicines, pain killers, anti-depressants, and
anti-psychotic drugs are affected. These include such important medications as Coumadin (warfarin), Prozac,
Zoloft, Paxil, Effexor, Hydrocodone, Amitriptyline, Claritin, Cyclobenzaprine, Haldol, Metoprolol, Rythmol,
Tagamet, Tamoxifen, Valium, Carisoprodol, Diazepam, Dilantin, Premarin, and Prevacid (and the over-the-counter
drugs, Allegra, Dytuss and Tusstat).
Genetic Glitches Common
More than half of all Americans have genetic defects that affect how they process these commonly used
prescription drugs. These DNA glitches can reduce the efficacy of drugs and lead to an increased incidence of
undesirable drug interactions. The most dangerous outcome is the build up of toxicity that can occur because of the
body's inability to eliminate the drug from the system.
Coumadin (warfarin) patients at especially high risk
One-third of patients taking Coumadin (warfarin) lack the DNA coding necessary to detoxify this dangerous drug
and fall into an especially high risk group. Clinical research has shown that one in eight will have a serious or life-
threatening adverse drug reaction to warfarin. They will also take more than 90 days longer to reach a stable
dosage. Genetic testing can readily identify patients who fall in this group.
Test Results
There are four main groups of classification:
• Extensive Metabolizer. This is the norm, medications prescribed in normal doses will be metabolized by
your body.
• Intermediate Metabolizer. This means that you have only one of two operating pathways, and will need a
lower than normal dosage and need to carefully monitor medication.
• Poor Metabolizer. This means you have no active pathways. There is a possibility that alternate routes can
be found, but this type of metabolizer is potentially very dangerous, as there is a great chance for the medication to
build up in your system making you very sick, or even killing you.
• Ultra Extensive Metabolizer. (2D6 only) This means you have more than two operating pathways.
Results should be given to your physician. Although the genetic component is the most important factor in
prescribing, there are numerous considerations that must be taken into account before deciding what treatment to
offer.
The Testing Process
The process is simple. We send you a buccal or blood collection kit in the mail, and you return samples to our
laboratory by priority mail. Results are typically available within 10 business days. Accelerated (STAT) five-day
testing is also available.
Warfarin/Coumadin Target Dose DNA Test

Every day millions of people take warfarin or Coumadin, powerful drugs used to control life
threatening conditions. How much of these medicines people need is difficult to determine and
often it takes several months of weekly clinic visits and blood tests.

Recent discoveries in DNA research make predicting the dose of warfarin a person needs much
more accurate, and of equal importance, how long it takes them to eliminate the drug. More than
half the population has variations in at least one of the two genes that are tested. These genetic
variations are responsible for almost half of the individual variation seen in warfarin dose.
Order this pair of DNA tests, now available from Genelex, and help your doctor help you to
reach your target dosage and INR (a measurement of your blood clotting levels) faster and safer.
Here's what a blue ribbon FDA advisory panel has to say about the genetics of
warfarin/Coumadin:

• Use lower doses of warfarin for patients with genetic variations in CYP2C9 and
or VKORC1 that lead to reduced activities.
• Genotyping patients in the induction phase of warfarin therapy would reduce
adverse events and improve achievement of stable INR.
• Existing evidence of the influence of CYP2C9 and VKORC1 genotypes warrants
re-labeling of warfarin to include genetic test information.

The FDA and others are sponsoring clinical trials to prove the extent to which using DNA
testing will reduce adverse bleeding events and save money. Many scientists believe that the use
of this testing will dramatically improve Warfarin efficacy and safety. In the meantime you can
order these tests now, share the results with your doctor and know that you're taking advantage
of the most recent scientific discoveries.

Genelex has available computer programs to help interpret the test results taking into account
your size, age and other medicines that you may be taking. Call Genelex today at 800-523-3080
to order testing for yourself or someone you care for, order on-line, or download the order form
and fax or mail in your order. Cost for the two genes with 4-day turnaround is only $550 and is
typically reimbursed by insurance.
Hemochromotosis DNA Test

Heriditary Hemochromatosis (HH) is regarded as the most common genetic disorder in Caucasians,
with an estimated prevalence of 1/200 (homozygotes - people with 2 copies of the mutation) and a carrier
frequency (heterozygotes, people with one copy of the mutation) of 1/8. This disorder involves excess
iron absorption and storage in organs and leads to high morbidity and mortality if untreated.
Hemochromatosis is preventable if diagnosed early. DNA testing is a valuable aid for early detection of
this disorder, detecting over 85% of cases.
Hemochromatosis Symptoms
Most homozygotes develop symptoms in adulthood, although the age of onset has been as young as 2
years. Symptoms tend to occur in men between the ages of 30 and 50 and in women over age 50.
However, many people have no symptoms when they are diagnosed. Joint pain is the most common
complaint of people with hemochromatosis. Other common symptoms include:
• Fatigue
• Lack of energy
• Abdominal pain
• Loss of sex drive
• Impotence
• Heart problems.
If the disease is not detected early and treated, iron may accumulate in body tissues and may
eventually lead to serious problems such as
• Arthritis
• Liver disease, including an enlarged liver, cirrhosis, cancer, and liver failure
• Damage to the pancreas, possibly causing diabetes
• Heart abnormalities, such as irregular heart rhythms or congestive heart failure
• Impotence
• Early menopause
• Abnormal pigmentation of the skin, making it look gray or bronze
• Thyroid deficiency
• Damage to the adrenal gland
The Testing Process
The process is simple. We send you a cheek swab collection kit in the mail. Samples are returned to our
laboratory and results are typically available in 5-7 business days.
Hemochromatosis DNA Testing Results
Two mutations associated with hemochromatosis have been discovered in the HFE gene. The major
mutation, Cys282Tyr (also known as 845A) is present in the homozygous state in 85% of Caucasians with
clinically diagnosed hemochromatosis. Most homozygotes (with two copies of the mutation) and some
heterozygotes (with one copy of the mutation) develop iron overload and hemochromatosis. A second
mutation, His63Asp (also known as 187G), appears to somewhat increase risk of iron overload. Although
only a small percent of individuals (up to 6%) with this mutation develop hemochromatosis, DNA testing
for hemochromatosis provides for effective early diagnosis and prevention.

Results include genetic consultation for physicians, patients, and families with board certified genetic
counselors.
Nutritional Genetic Testing with Consultation or DNA Diet 2 Week Menu Plan

Gene Analysis for Long Term Optimal Health


Optimize the health of your skin and bones; heart and mind by optimizing your personal diet and supplement
intake. Genetic testing combined with a lifestyle assessment, provide you with a scientifically based, personal
blueprint for optimizing health.
Testing examines your personal variations in nineteen genes play roles in your body's heart and bone health,
detoxification and antioxidant capacity, insulin sensitivity, and tissue repair. Your DNA test results, combined
with information from your completed lifestyle questionnaire, result in personalized, realistic steps you can take
to improve and maintain your good health. Benefits may include:
• Reduced cravings caused by nutrients missing from your diet.
• Optimize the health and durability of your skin, hair and bones.
• Harmonize your diet and life-style with your genome by learning about genetically related risk factors
to the big three diseases – heart disease, cancer, and diabetes, that your diet can influence.
• Easier compliance with your self-improvement program because personalized advice lets you know
that what you are doing is based on your unique needs and will be effective.
Recommendations are based on analysis of a panel of genes referenced against your lifestyle questionnaire, and
include customized dietary and nutritional supplementation programs. Information about the following seven
areas in which the link between gene variations and lifestyle has been noted is included in the testing and
recommendations:
• Heart Health. Some genetic factors may increase the risk that certain individuals will develop heart
disease. Simple, easy-to-follow advice may help reduce that risk.
• Bone Health. Certain genetic factors indicate a need for foods that provide your bones with the
nutrients they require to stay strong. Specific foods that will help solve this problem are listed.
• B Vitamin Use. Many people have genetic variations that interfere with the way their bodies use B
vitamins, an important factor in cell growth and maintenance. Use of recommended supplements can
solve this common problem.
• Detoxification. Genes can determine how well your body cleanses itself of harmful toxins. If
necessary, we recommend specific foods to give your cleansing systems a healthy boost.
• Antioxidants. A genetically determined level of antioxidants controls how well our bodies neutralize
free radicals, destructive molecules involved in aging and a variety of diseases. Supplementation can
help minimize these destructive effects.
• Inflammation. Depending on your genetic profile, you may need certain foods to fight damaging
inflammation.
• Insulin Sensitivity. If your genes increase your risk of insulin sensitivity, we will recommend dietary
and lifestyle changes that may help prevent this condition.
The advice you will get from us is based on your body’s real needs, not on the latest dietary fad.

Genelex accompanies this test with either a consultation with our nutritionist Carolyn Katzin to
help understand, and personalize your DNA testing results to your diet and lifestyle, or a more
comprehensive 2 week menu plan called “The DNA Diet” Based on your genetic results.

In addition to alerting you to diet and lifestyle factors to which you should pay particular attention, we provide
you with personalized suggestions for nutritional supplementation that will enhance your health and well-being.
Call or visit us on the web for more details.
Celiac Disease DNA Test

Were you wrongly diagnosed with Irritable bowel syndrome (IBS) and are still searching for answers?
Has a family member been diagnosed with celiac disease and you are concerned about your risk?
Are you on a gluten-free diet making standard celiac testing impossible?
Do you have undiagnosed gastrointestinal symptoms and want to rule out celiac disease?
Are you iron deficient?
Have you been diagnosed with osteoporosis?
Do you have undiagnosed non-gastrointestinal symptoms and want to rule out celiac disease?
Have you had a borderline or ambiguous antibody or small bowel biopsy result?
Do you have dermatitis herpetiformis?
If you answered yes to any of these questions, Celiac Disease DNA testing is recommended.
Celiac Disease, also known as gluten intolerance or celiac sprue, is a genetically influenced chronic autoimmune
disorder recognized to affect approximately 1 in 100 Americans, particularly those of European descent. A toxic
reaction to gluten (found in barley, wheat, and rye) causes damage to the surface of the small intestine that
interferes with the absorption of nutrients, and can cause extremely varied symptoms. Due to the wide range of
symptoms, Celiac disease is a highly underdiagnosed condition with approximately 90% of cases currently going
undetected. Early diagnosis and lifelong treatment with a gluten-free diet is critical for both symptom relief and
reducing the risk of developing long-term conditions such as diabetes or GI cancer.
Celiac Disease DNA testing is not used to diagnose celiac disease, but can quickly, accurately, and painlessly
exclude the diagnosis as you must have certain genetic markers in order to develop Celiac disease. According to a
recent NIH study, a typical patient currently endures 11 years of symptoms before an accurate diagnosis is found.
Since the traditional approach requires blood tests, small intestine biopsies and six months on a gluten-free diet
before confirmed diagnosis, many prefer Celiac DNA testing.
The Testing Process
The process is simple. We send you a cheek swab collection kit in the mail. Samples are returned to our laboratory
and results are typically available in 3 business days.
Celiac DNA Testing Results
Celiac Disease DNA testing is not used to diagnose celiac disease, but can quickly, accurately, and painlessly
exclude the diagnosis as you must have certain genetic markers in order to develop Celiac disease. A negative
results means that you are not at risk of developing Celiac disease. A positive result in addition to clinical
symptoms, indicates the need for referral to a gastroenterologist.
Results include genetic consultation for physicians, patients, and families with board certified genetic counselors.
If you are concerned that you may have Celiac disease, call 800-523-3080 to order your Celiac Disease DNA test
for only $445.
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