Test to treat - Oncomine PDFs/TFS-CLI-1088… · Low Tumor Content Samples: Single-Gene Tests, NGS,...
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Because the Oncomine Dx Target Test has low sample requirements, you can test to enable treatment of more NSCLC patients. Test to treat more patients with the Oncomine Dx Target Test Find out more at thermofisher.com/oncomine-dxtarget The figures used above are based on published sample requirements for both tests. The Oncomine Dx Target Test is approved for use with formalin-fixed, paraffin-embedded (FFPE) tissue from NSCLC surgical resections and CNBs. For In Vitro Diagnostic Use. © 2018 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. FoundationOne CDx is a trademark of FOUNDATION MEDICINE, INC. COL06082 0418 Not every NGS test has the same low sample requirements. Comparison of two FDA-approved companion diagnostic (CDx) tests: FoundationOne CDx test Oncomine Dx Target Test 50 ng–1,000 ng Minimum input requirement Entire block or 10 slides 2 slides for resection, 9 for CNB Number of slides required Minimum sample surface area 20% min–30% optimal Minimum tumor content 10 ng 10% No minimum requirement FoundationOne CDx ™ test requires a minimum of 25 mm 2 tumor area, while Oncomine Dx Target Test has no minimum restriction on tumor area. 3. 25 mm 2 minimum NGS test input requirements are typically expressed as X ng of nucleic acid, and can differ significantly between different tests. The figures below explain the practical implications of these different requirements in terms of tissue, tumor area, and content. 1. Similar number of slides are required for both tests. 2. The percentage of tumor tissue required in the area is lower for Oncomine Dx Target Test. 4. Tissue requirements rise and success rates fall as more results are performed with single-gene methods. The Ion Torrent ™ Oncomine ™ Dx Target Test achieves 71% success with only 1 tissue slide. As more genes are required, slide consumption when using single-gene methods continues to increase (in some cases requiring 19 slides), but the success rate continues to fall. The sample used for the Oncomine Dx Target Test was restricted to only one slide for this study. Slides consumed for CNBs with 1–24% tumor content When requirement of number of genes increased, success rate tends to decline. When 4 genes are required, only 71% of patients received results. Testing success rates for the Oncomine Dx Target Test using just one slide were comparable to single-gene testing for ≥4 biomarkers on low-tumor content CNBs and ≥5 biomarkers on CNBs with ≥25% tumor content. The figures used above are based on: Yu T, Morrison C, Gold E et al. (2017). Retrospective Analysis of NSCLC Testing in Low Tumor Content Samples: Single-Gene Tests, NGS, & the Oncomine™ Dx Target Test. J Thorac Oncol 12:S1845. Number of genes Number of slides Number of genes 95% 70% 88% 71% 71% 62% 60% 3 1 Success rate Percent of patients successfully tested for CNBs with 1–24% tumor content 5 2 6 3 10 4 12 5 19 6 23 1 2 3 4 5 6 23 NSCLC tissue samples are small and challenging to test. 1,324 routine clinical NSCLC samples were tested by single-gene methods. The majority of these samples were CNBs, of which 21% had tumor content below 25%. 76.0% 21% <25% tumor content >25% tumor content 79% Fine needle aspirate (FNA) 144 samples Total of 1,324 NSCLC samples Core needle biopsies (CNBs) 1,029 samples Surgical resections 181 samples 10.6% 13.4% Clinical practice guidelines recommend broad genetic profiling for advanced non-small cell lung cancer (NSCLC) to guide first-line treatment. Small biopsies and low–tumor content samples pose challenges to testing of an increasing number of relevant biomarkers. Next-generation sequencing (NGS) can help address these challenges, but not all NGS is the same. Test to treat more NSCLC patients
Transcript of Test to treat - Oncomine PDFs/TFS-CLI-1088… · Low Tumor Content Samples: Single-Gene Tests, NGS,...
Because the Oncomine Dx Target Test has low sample requirements, you can test to enable treatment of more NSCLC patients.
Test to treat more patients with the Oncomine Dx Target Test
Find out more at thermofisher.com/oncomine-dxtarget
The figures used above are based on published sample requirements for both tests. The Oncomine Dx Target Test is approved for use with formalin-fixed, para�n-embedded (FFPE) tissue from NSCLC surgical resections and CNBs.
For In Vitro Diagnostic Use. © 2018 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. FoundationOne CDx is a trademark of FOUNDATION MEDICINE, INC. COL06082 0418
Not every NGS test has the same low sample requirements. Comparison of two FDA-approved
companion diagnostic (CDx) tests:
FoundationOne CDx test
Oncomine Dx Target Test
50 ng–1,000 ng
Minimum input requirement
Entire block or 10 slides 2 slides for resection, 9 for CNB
Number of slides required
Minimum sample surface area
20% min–30% optimal
Minimum tumor content
10 ng
10%
No minimum requirement
FoundationOne CDx™ test requires a minimum of 25 mm2 tumor area, while Oncomine Dx Target Test has no minimum restriction on tumor area.
3.
25 mm2 minimum
NGS test input requirements are typically expressed as X ng of nucleic acid, and can di�er significantly between di�erent tests. The figures below explain the practical implications of these di�erent requirements in terms of tissue, tumor area, and content.
1.
Similar number of slides are required for both tests.
2.
The percentage of tumor tissue required in the area is lower for Oncomine Dx Target Test.
4.
Tissue requirements rise and success rates fallas more results are performed with single-gene methods.
The Ion Torrent™ Oncomine™ Dx Target Test achieves71% success with only 1 tissue slide.
As more genes are required, slide consumption when using single-gene methods continues to increase (in some cases requiring 19 slides), but the success rate continues to fall. The sample used for the Oncomine Dx Target Test was restricted to only one slide for this study.
Slides consumed for CNBs with 1–24% tumor content
When requirement of number of genes increased, success rate tends to decline. When 4 genes are required, only 71% of patients received results. Testing success rates for the Oncomine Dx Target Test using just one slide were comparable to single-gene testing for ≥4 biomarkers on low-tumor content CNBs and ≥5 biomarkers on CNBs with ≥25% tumor content.
The figures used above are based on: Yu T, Morrison C, Gold E et al. (2017). Retrospective Analysis of NSCLC Testing in Low Tumor Content Samples: Single-Gene Tests, NGS, & the Oncomine™ Dx Target Test. J Thorac Oncol 12:S1845.
Number of genes
Num
ber
of s
lides
Number of genes
95%
70%
88%
71% 71%62% 60%
3
1
Suc
cess
rat
e
Percent of patients successfully tested for CNBs with 1–24% tumor content
5
2
6
3
10
4
12
5
19
6 23
1 2 3 4 5 6 23
NSCLC tissue samples are small and challenging to test.
1,324 routine clinical NSCLC samples were tested by single-gene methods. The majority of these samples were CNBs, of which 21% had tumor content below 25%.76.0%
21%<25%
tumor content
>25%tumor
content
79%
Fine needle aspirate (FNA)144 samples
Total of1,324
NSCLCsamples
Core needle biopsies (CNBs)
1,029 samples
Surgical resections181 samples 10.6%
13.4%
Clinical practice guidelines recommend broad genetic profiling for advanced non-small cell lung cancer (NSCLC) to guide first-line treatment.
Small biopsies and low–tumor content samples pose challenges to testing of an increasing number of relevant biomarkers.
Next-generation sequencing (NGS) can help address these challenges, but not all NGS is the same.
Test to treatmore NSCLC patients
Because the Oncomine Dx Target Test has low sample requirements, you can test to enable treatment of more NSCLC patients.
Test to treat more patients with the Oncomine Dx Target Test
For In Vitro Diagnostic Use. © 2018 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. FoundationOne CDx is a trademark of FOUNDATION MEDICINE, INC. COL06082 0418
Find out more at thermofisher.com/oncomine-dxtarget
When requirement of number of genes increased, success rate tends to decline. When 4 genes are required, only 71% of patients received results. Testing success rates for the Oncomine Dx Target Test using just one slide were comparable to single-gene testing for ≥4 biomarkers on low-tumor content CNBs and ≥5 biomarkers on CNBs with ≥25% tumor content.
The figures used above are based on: Yu T, Morrison C, Gold E et al. (2017). Retrospective Analysis of NSCLC Testing in Low Tumor Content Samples: Single-Gene Tests, NGS, & the Oncomine™ Dx Target Test. J Thorac Oncol 12:S1845.
Tissue requirements rise and success rates fallas more results are performed with single-gene methods.
The Ion Torrent™ Oncomine™ Dx Target Test achieves71% success with only 1 tissue slide.
As more genes are required, slide consumption when using single-gene methods continues to increase (in some cases requiring 19 slides), but the success rate continues to fall. The sample used for the Oncomine Dx Target Test was restricted to only one slide for this study.
Slides consumed for CNBs with 1–24% tumor content
Number of genes
Num
ber
of s
lides
Number of genes
95%
70%
88%
71% 71%62% 60%
3
1
Suc
cess
rat
e
Percent of patients successfully tested for CNBs with 1–24% tumor content
5
2
6
3
10
4
12
5
19
6 23
1 2 3 4 5 6 23
NSCLC tissue samples are small and challenging to test.
1,324 routine clinical NSCLC samples were tested by single-gene methods. The majority of these samples were CNBs, of which 21% had tumor content below 25%.76.0%
21%<25%
tumor content
>25%tumor
content
79%
Fine needle aspirate (FNA)144 samples
Total of1,324
NSCLCsamples
Core needle biopsies (CNBs)
1,029 samples
Surgical resections181 samples 10.6%
13.4%
Clinical practice guidelines recommend broad genetic profiling for advanced non-small cell lung cancer (NSCLC) to guide first-line treatment.
Small biopsies and low–tumor content samples pose challenges to testing of an increasing number of relevant biomarkers.
Next-generation sequencing (NGS) can help address these challenges.
Test to treatmore NSCLC patients
Because the Oncomine Dx Target Test has low sample requirements, you can test to enable treatment of more NSCLC patients.
Test to treat more patients with the Oncomine Dx Target Test
For In Vitro Diagnostic Use. © 2018 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. FoundationOne CDx is a trademark of FOUNDATION MEDICINE, INC. COL06082 0418
Find out more at thermofisher.com/oncomine-dxtarget
The figures used above are based on published sample requirements for both tests. The Oncomine Dx Target Test is approved for use with formalin-fixed, para�n-embedded (FFPE) tissue from NSCLC surgical resections and CNBs.
Not every NGS test has the same low sample requirements. Comparison of two FDA-approved
companion diagnostic (CDx) tests:
FoundationOne CDx test
Oncomine Dx Target Test
Minimum input requirement
2 slides for resection, 9 for CNB
Number of slides required
Minimum sample surface area
Minimum tumor content
10 ng
10%
No minimum requirement
50 ng–1,000 ng
Entire block or 10 slides
20% min–30% optimal
FoundationOne CDx™ test requires a minimum of 25 mm2 tumor area, while Oncomine Dx Target Test has no minimum restriction on tumor area.
3.
25 mm2 minimum
NGS test input requirements are typically expressed as X ng of nucleic acid, and can di�er significantly between di�erent tests. The figures below explain the practical implications of these di�erent requirements in terms of tissue, tumor area, and content.
1.
Similar number of slides are required for both tests.
2.
The percentage of tumor tissue required in the area is lower for Oncomine Dx Target Test.
4.
Clinical practice guidelines recommend broad genetic profiling for advanced non-small cell lung cancer (NSCLC) to guide first-line treatment.
Small biopsies and low–tumor content samples pose challenges to testing of an increasing number of relevant biomarkers.
Next-generation sequencing (NGS) can help address these challenges by detecting more biomarkers in one test, however, not all NGS requires the same small amount of sample.
Test to treatmore NSCLC patients
