Facing a Global Challenge: Fit for the

Future with Intelligent Screening Strategies

for GMO Detection
Katharina Schmauder
Eurofins GeneScan Technologies

Setting Standards www.eurofins.com/kits

Agenda

Principles of GMO Testing

Analytical Strategies for GMO Testing

Intelligent Screening Strategies: GMO Soybean

Intelligent Screening Strategies: GMO Corn

Optimized GMO Testing

Setting Standards 2
Agenda

Principles of GMO Testing

Analytical Strategies for GMO Testing

Intelligent Screening Strategies: GMO Soybean

Intelligent Screening Strategies: GMO Corn

Optimized GMO Testing

Setting Standards 3
GMO Detection

Broad and Cost Efficient Testing

accidential customer
demand special
release of
requirements
GMOs

legal
potential
framework in
botanical
country of
impurities
destination Combination
of PCR targets
commercial should cover relevant
planting formulation /
in the country
GMOs raw materials
of origin

Setting Standards 4
GMO Testing: Basic Approach

Question:
Qualitative
Does the sample contain
GMO Screening
GMO Material?

Question:
Identification of Does the sample contain
GMO unapproved GMOs?

Question:
Quantification of Does the product have
the GMO content to be labelled?

Setting Standards 5
GMO Detection with PCR

Specificity of Detection Methods

genomic
Prom. Enh. CTP CDS Term.
sequence
screening
targets

Element-specific

Gene-specific

Modification-specific
specific
targets

Event (Line)-specific

Setting Standards 6
Agenda

Principles of GMO Testing

Analytical Strategies for GMO Testing

Intelligent Screening Strategies: GMO Soybean

Intelligent Screening Strategies: GMO Corn

Optimized GMO Testing

Setting Standards 7
GMO Testing – Sample Types

Characterization Depending on the GMO‘s Approval Status

NON-GM Samples

Presence of a GMO or GM material that is authorized for commercial use

or sale in the importing country.

Presence of a GMO or GM material that is authorized for commercial use

or sale in one or more countries but is not authorized in the importing country

Unintentional presence of GM crops that have not been approved

in any country.

Setting Standards 8
GMO Testing Strategies: non-GM

GMO content not expected in the sample

Qualitative scope of screening depends on

Screening for the ingredients
presence of GMOs

e.g. exclusion of non-approved GMO,

Identification of depending on risk assessment of
GMOs possible presence, or identification of
approved GMO

Quantification of
check for labelling requirements
the GMO content

Setting Standards 9
GMO Testing Strategies: GMO likely

GMO content expected in the sample

Qualitative screening for the

Direct quantification of
presence of unexpected / plus
expected GMOs
unapproved GMOs

Identification of GMOs

Quantification of the GMO

content

Setting Standards 10
Coverage with 35S/NOS Screening

The figure shows the coverage with 35S/NOS screening for corn, soybean, cotton and canola GMOs

120

100

80

60

40

20

0
94 96 98 00 02 04 06 08 10 12 14 16
35S and/or nos positive 35S and nos negative

Setting Standards 11
Coverage with 35S/NOS Screening

Genetically Modified Corn and Soybean

11,90% 35S and NOS 11,90%

35S, NOS and FMV
negative corn
negative corn
35S or NOS 35S, NOS or FMV
positive corn positive corn
88,10% 88,10%

35S and NOS 35S, NOS and FMV

negative soybean 37,50% negative soybean
54,17% 45,83% 62,50%
35S or NOS 35S, NOS or FMV
positive soybean positive soybean

 New screening approaches covering the most important GM events are required

Setting Standards
Agenda

Principles of GMO Testing

Analytical Strategies for GMO Testing

Intelligent Screening Strategies: GMO Soybean

Intelligent Screening Strategies: GMO Corn

Optimized GMO Testing

Setting Standards 13
GMO Soy – Commercialization

GMO EU approval planting The table lists all GMOs with EU authorization
status and pending approvals
GTS 40-3-2 app. +
MON89788 app. +
MON87701 app. + app.: approved for food and feed in the EU
MON87708 app. +
pend.: pending approval in the EU
MON87705 app. +
A2704-12 app. + 0,1% feed: tolerated in feed in a proportion
A5547-127 app. + no higher than 0,1% according to
CV127 app. + Regulation (EC) No. 619/2011
FG72 app. +
app. +
planting: commercial or closed loop planting in
305423
one or more countries according to
356043 app.
CropLife International and other
MON87769 app.
sources
DAS-68416-4 app.
DAS-44406-6 app.
DAS-81419-2 pend., 0,1% feed
SYHT0H2 pend.
MON87751 pend.

Setting Standards 14
Detection of GMO Soybean

GMO EU approval status 35S NOS FMV

GTS 40-3-2 app. + +
MON89788 app. +
MON87701 app.
MON87708 app.
MON87705 app. +
A2704-12 app. +
A5547-127 app. +
CV127 app.
FG72 app. +
MON87769 app.
305423 app.
356043 app. +
DAS-68416-4 app.
DAS-44406-6 app.
DAS-81419-2 pend., 0,1% feed
SYHT0H2 pend. + + +
MON87751 pend.

Setting Standards 15
Detection of GMO Soybean

GMO EU approval status 35S NOS FMV ABII

GTS 40-3-2 app. + +
MON89788 app. + +
MON87701 app. +
MON87708 app. +
MON87705 app. + +
A2704-12 app. +
A5547-127 app. +
CV127 app.
FG72 app. +
MON87769 app. +
305423 app.
356043 app. +
DAS-68416-4 app.
DAS-44406-6 app.
DAS-81419-2 pend., 0,1% feed
SYHT0H2 pend. + + +
MON87751 pend. +

Setting Standards 16
Detection of GMO Soybean

GMO EU approval status 35S NOS FMV ABII 305423 CV127

GTS 40-3-2 app. + +
MON89788 app. + +
MON87701 app. +
MON87708 app. +
MON87705 app. + +
A2704-12 app. +
A5547-127 app. +
CV127 app. +
FG72 app. +
MON87769 app. +
305423 app. +
356043 app. +
DAS-68416-4 app.
DAS-44406-6 app.
DAS-81419-2 pend., 0,1% feed
SYHT0H2 pend. + + +
MON87751 pend. +

Setting Standards 17
Detection of GMO Soybean

GMO EU approval status 35S NOS FMV ABII 305423 CV127 CsVMV
GTS 40-3-2 app. + +
MON89788 app. + +
MON87701 app. +
MON87708 app. +
MON87705 app. + +
A2704-12 app. +
A5547-127 app. +
CV127 app. +
FG72 app. +
MON87769 app. +
305423 app. +
356043 app. +
DAS-68416-4 app. +
DAS-44406-6 app. +
DAS-81419-2 pend., 0,1% feed +
SYHT0H2 pend. + + +
MON87751 pend. +

Setting Standards 18
Basic Screening for GMO Soybean

Recommended First Level Detection

• GMOScreen 35S / NOS / ABII
Multiplex kit containing:
• Optimized 35S promoter method detects also related promoter elements
• NOS terminator detection for important corn events with no 35S promoter
such as FG72 or HB4 soybean
• AgroBorder II covers more genetically modified soybean than the FMV
promoter detection method.
• GMOIdent CsVMV / CV127 / 305423 Soybean
A new multiplex kit for specific detection of five soybean events lacking the
above mentioned screening elements.
• DAS-44406-6, DAS-81419-2, DAS-68416-4 (CsVMV detection)
• CV127
• 305423

Setting Standards 19
Multiplex Screenig of GMO Soybean

First Level Screening/Identification

CsVMV

CV127
NOS

ABII
EU approval

35S

305423
GMO Planting
status

Multiplex Assay Multiplex Assay

GTS 40-3-2 app. + + +

MON89788 app. + +
MON87701 app. + +
MON87708 app. + +
MON87705 app. + +
A2704-12 app. + +
A5547-127 app. + +
CV127 app. + +
FG72 app. + +
305423 app. + +

app: approved for food and feed in the EU

planting: commercial or closed loop planting in one or more countries according to CropLife International and other sources

Setting Standards 20
Multiplex Screenig of GMO Soybean

First Level Screening/Identification

CsVMV

CV127
NOS

ABII
EU approval

35S

305423
GMO Planting
status

Multiplex Assay Multiplex Assay

356043 app. +
MON87769 app. +
DAS-68416-4 app. +

DAS-44406-6 app. +
pend.,
DAS-81419-2 +
0,1% feed

SYHT0H2 pend. + +
MON87751 pend. +

app.: approved for food and feed in the EU

pend.: pending approval in the EU, 0,1% feed:tolerated in feed in a proportion no higher than 0,1% according to
Regulation (EC) No. 619/2011

planting: commercial or closed loop planting in one or more countries according to CropLife International and other sources

Setting Standards 21
Agenda

Principles of GMO Testing

Analytical Strategies for GMO Testing

Intelligent Screening Strategies: GMO Soybean

Intelligent Screening Strategies: GMO Corn

Optimized GMO Testing

Setting Standards 22
GMO Corn – Commercialization

Genetically modified corn

GMO EU approval planting
status with valid EU approval
Bt11 app. +
GA21 app. +
planting: commercial or closed loop planting
TC1507 app. + in one or more countries according
DAS-59122-7 app. + to CropLife International and other
T25 app. + sources
MIR604 app. +
MON810 app. +
MON88017 app. +
MON89034 app. +
NK603 app. +
MIR162 app. +
DAS-40278-9 app. +
MON87460 app.
MON87427 app.

Setting Standards 23
GMO Corn – Commercialization

GMO EU approval planting Genetically modified corn with pending or

status expired EU approval
3272 pend. , 0,1% feed
pend.: pending approval in the EU
event 5307 pend. , 0,1% feed
VCO-01981-5 pend. , 0,1% feed exp.: approval expired
DP-098140-6 pend.
withdr.: application for authorization
MON87411 pend. withdrawn
MON87403 pend.
0,1% feed: tolerated in feed in a proportion
DP-004114-3 pend.
no higher than 0,1% according to
MZHG0JG pend. Regulation (EC) No. 619/2011
MON87419 pend.
MZIR098 pend.
disc.: discontinued commercial planting
according to CropLife International
Bt 176 exp., 0,1% feed disc.
and other sources, contaminations
MON863 exp., 0,1% feed disc. with this GMO can not be
LY038 withdr. excluded

Setting Standards 24
Multiplex Screening of GMO Corn

First Level Screening/Identification

NOS

ABII
EU approval

35S
GMO Planting
status

Multiplex Assay
Bt11 appr. + + +
GA21 appr. + +
TC1507 appr. + +
DAS-59122-7 appr. + +
T25 appr. + +
MIR604 appr. + +
MON810 appr. + +
MON88017 appr. + + + +
MON89034 appr. + + + +
NK603 appr. + + +
MIR162 appr. + +
DAS-40278-9 appr. +
MON87460 appr. + + +
MON87427 appr. + + +

Setting Standards 25
Multiplex Screening of GMO Corn

First Level Screening/Identification

DAS-40278-9
Event
NOS

ABII
EU approval

35S
GMO Planting
status

Multiplex Assay
Bt11 appr. + + +
GA21 appr. + +
TC1507 appr. + +
DAS-59122-7 appr. + +
T25 appr. + +
MIR604 appr. + +
MON810 appr. + +
MON88017 appr. + + + +
MON89034 appr. + + + +
NK603 appr. + + +
MIR162 appr. + +
DAS-40278-9 appr. + +
MON87460 appr. + + +
MON87427 appr. + + +

Setting Standards 26
Multiplex Screening of GMO Corn

First Level Screening/Identification

DAS-40278-9
Event
NOS

ABII
35S
GMO EU approval status

Multiplex Assay
3272 pend. , 0,1% feed +
event 5307 pend. , 0,1% feed +
VCO-01981-5 pend. , 0,1% feed
Event 98140 pend. , 0,1% feed +
MON87411 pend. + +
MON87403 pend. + +
DP-004114-3 pend. +
MZHG0JG pend. + +
MON87419 pend. +
MZIR098 pend. + +
Bt 176 exp., 0,1% feed +
MON863 exp., 0,1% feed + +
LY038 withdr.

Setting Standards 27
Multiplex Screening of GMO Corn

First Level Screening/Identification

VCO-01981-5

DAS-40278-9

LY038
Event

Event
NOS

ABII
35S
GMO EU approval status

Multiplex Assay Multiplex Assay

3272 pend. , 0,1% feed +
event 5307 pend. , 0,1% feed +
VCO-01981-5 pend. , 0,1% feed +
Event 98140 pend. , 0,1% feed +
MON87411 pend. + +
MON87403 pend. + +
DP-004114-3 pend. +
MZHG0JG pend. + +
MON87419 pend. +
MZIR098 pend. + +
Bt 176 exp., 0,1% feed +
MON863 exp., 0,1% feed + +
LY038 withdr. +

Setting Standards 28
Basic Screening for GMO Corn

Recommended First Level Detection

• GMOScreen 35S / NOS / ABII
Multiplex kit containing:
• Optimized 35S promoter method detects also related promoter elements,
as present e.g. present in Optimum GAT™ corn (event DP-098140-6)
• NOS terminator detection for important corn events with no 35S promoter
element such as GA21, MIR162, MIR604 and others
• AgroBorder II screening provides additional information about GMOs and
covers upcoming corn events such as MON87419
• GMOIdent VCO-01981-5 / DAS-40278-9 / Ly038 Corn
A new multiplex kit for specific detection of three corn events lacking the above
mentioned screening elements.
• VCO-01981-5
• DAS-40278-9
• LY038

Setting Standards 29
Agenda

Principles of GMO Testing

Analytical Strategies for GMO Testing

Intelligent Screening Strategies: GMO Soybean

Intelligent Screening Strategies: GMO Corn

Optimized GMO Testing

Setting Standards 30
Optimized Screening

Enhanced Lab Efficiency with

Optimized Qualitative Screening Tools

• The 35S/NOS/ABII multiplex is an intelligent and efficient tool for a first level screening for
the most important GMOs in corn and soybean samples
• Optional additional modules can be used to offer a comprehensive screening for the food,
feed and seed industry

Setting Standards 31
GMO Testing: Basic Approach

Question:
Qualitative
Does the sample contain
GMO Screening
GMO Material?

Question:
Identification of Does the sample contain
GMO unapproved GMOs?

Question:
Quantification of Does the product have
the GMO content to be labelled?

Setting Standards 32
Optimize Your GMO Testing

Minimize The Number of Tests and Costs – Take Shortcuts

• Take into consideration the species listed

for the sample (and botanical impurities in case)
• Use efficient screening strategies
with intelligent multiplex approaches
• Combine the results of appropriate screening tests
• Use screening quantification if non-approved GMOs can be
excluded
• Alternatively reduce candidates of potential approved GMOs for
quantitative testing by further screenings or identification

Setting Standards 33
 Thank you for your attention!
Questions?

Setting Standards 34