Oncotype SEQ® Liquid Select

Oncotype SEQ Liquid Select is a clinically actionable mutation panel that provides physicians with insight into treatment considerations based on genomic tumor markers in their patients blood.

These mutation markers may indicate that the patient is sensitive or resistant to approved molecular marker-associated therapies, or may be eligible for actively recruiting clinical trials

Clinically Actionable

The 17-gene Oncotype SEQ Liquid Select panel is focused on clinically actionable genes where NCCN® guideline inclusions are available to support therapy selection for stage IV solid tumors, including lung, breast, colon, melanoma, ovarian, and gastrointestinal stromal tumor (GIST). Additionally, the panel identifies actively enrolling Phase II-IV clinical trials that your patient may be eligible for on the basis of the genomic alterations associated with their disease.


Clinically Actionable (Therapy Selection)

Somatic variant has therapeutic impact for treatment of cancer based on:

  • Inclusion in FDA drug label
  • Inclusion in NCCN Guidelines
  • Inclusion in NCCN Guidelines as an emerging marker
  • Basis for referral to a Phase II-IV clinical trial

Stage IV Patient Clinical Trial Matching (Phase I Excluded)

Cancer Panel Coverage (%) of all Potential Trials Number of Matched Trials
Lung 90% 155 trials
Breast 94% 88 trials
Colon 93% 81 trials
Melanoma 88% 136 trials
Ovarian 93% 83 trials
GIST 89% 85 trials

Built for Today and Tomorrow

In addition to including all guideline included molecular markers for approved treatments, the panel includes select emerging markers that are showing promise for inclusion in guidelines.

ALK BRCA1 BRCA2 BRAF EGFR ERRB2 KRAS PDGFRA CKIT NRAS MET RET ROS AR ESR1 PIK3CA PTEN
Associated with FDA - approved treatment in major solid tumors ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎
Included in guidelines with a therapy recommendation ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎
Included in guidelines as emerging marker
Emerging alterations, likely to be in guidelines
♦︎ Therapy recommendation
◊ Emerging marker

The Oncotype SEQ Liquid Select panel contains all alterations associated with approved therapies in NCCN guidelines for stage IV solid tumors.

HER2 Targeted Therapies EGFR Targeted Therapies Other Kinase Inhibitors PARP Inhibitor
Approved in Stage IV Solid Tumors Afatinib Lapatinib Pertuzumab Trastuzumab Ado-Trastuzumab Emtansine Afatinib Erlotinib Gefitinib Osimeritinib Cetuximab Panitumumab Ceritinib Crizotinib Dabrafenib Trametinib Vemurafenib Imatinib Cabozantinib Alectinib Oliparib
ALK ♦︎ ♦︎ ♦︎
BRCA1 ♦︎
BRCA2 ♦︎
BRAF ♦︎ ♦︎ ♦︎
EGFR† ♦︎ ♦︎ ♦︎ ♦︎ ♦︎
ERBB2 ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎
KRAS
PDGFRA‡
C-KIT‡
NRAS
MET
RET
ROS
♦︎ Marker included in FDA text associated with drug
◊ Marker associated with drug Resistance in FDA text
■ Included in Guidelines
Resistance association in Guidelines
† EGFR T790M mutation, in conjunction with a sensitizing mutation, confers resistance for EGFR tyrosine kinase inhibitors except Osimertinib, Rociletinib is under FDA review for treatment of patients with mutant EGFR non-small cell lung cancer, who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.
‡ Most alterations in PDGFRA and c-KIT are sensitive to imatinib with the exception of PDGFRA D842 and c-KIT D816V (NCCN 2017, imatinib PI). PDGFRA and c-KIT mutation testing is presently indicated for imatinib use in certain diseases other than solid tumors.

The Oncotype SEQ Liquid Select panel includes select emerging markers that are enrollment criteria for promising clinical trials.

Select Genes Currently Being Used in Clinical Trials for Stage IV Solid Tumors HER2 Targeted Therapies EGFR Inhibitors mTOR Inhibitors Other Kinase Inhibitors Anti-Hormonal Agents Androgen Receptor Targeted Therapies
ERBB2
BRAF
ROS
MET
AR
ESR1
PIK3CA
PTEN

Performance Specifications

SNVs Indels Fusions CNV (gain)
Analytical Performance* Sensitivity Level to achieve a 95% detection rate† 0.56% AF 0.19% AF 0.37% AF 2.7 copies
Lowest level detected‡ 0.1% AF 0.1% AF 0.1% AF 2.4 copies
Specificity per sample >99% >99% >99% >99%
TAT Target: 90% ≤ 14 days from receipt
Sample Requirements 2 x 10mL blood
* Demonstrated in Analytical Validation with variant positive reference cell line samples (n=105) at 30-50ng DNA input. Detection limits were selected above the Limit of Blank (LOB) corresponding to >99% per sample specificity (and >99.9999% per base specificity) among 73 cfDNA samples from 60 healthy volunteers.
† Represents mean mutant allele fraction (AF)/copies across variants tested.
‡ Lowest level tested during analytical validation. Levels lower than this may be reported.

Oncotype SEQ Liquid Select is a clinically actionable mutation panel that provides physicians with insight into treatment considerations based on genomic tumor markers in their patients blood.

These mutation markers may indicate that the patient is sensitive or resistant to approved molecular marker-associated therapies, or may be eligible for actively recruiting clinical trials

Clinically Actionable

The 17-gene Oncotype SEQ Liquid Select panel is focused on clinically actionable genes where NCCN® guideline inclusions are available to support therapy selection for stage IV solid tumors, including lung, breast, colon, melanoma, ovarian, and gastrointestinal stromal tumor (GIST). Additionally, the panel identifies actively enrolling Phase II-IV clinical trials that your patient may be eligible for on the basis of the genomic alterations associated with their disease.


Clinically Actionable (Therapy Selection)

Somatic variant has therapeutic impact for treatment of cancer based on:

  • Inclusion in FDA drug label
  • Inclusion in NCCN Guidelines
  • Inclusion in NCCN Guidelines as an emerging marker
  • Basis for referral to a Phase II-IV clinical trial

Stage IV Patient Clinical Trial Matching (Phase I Excluded)

Cancer Panel Coverage (%) of all Potential Trials Number of Matched Trials
Lung 90% 155 trials
Breast 94% 88 trials
Colon 93% 81 trials
Melanoma 88% 136 trials
Ovarian 93% 83 trials
GIST 89% 85 trials

Built for Today and Tomorrow

In addition to including all guideline included molecular markers for approved treatments, the panel includes select emerging markers that are showing promise for inclusion in guidelines.

ALK BRCA1 BRCA2 BRAF EGFR ERRB2 KRAS PDGFRA CKIT NRAS MET RET ROS AR ESR1 PIK3CA PTEN
Associated with FDA - approved treatment in major solid tumors ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎
Included in guidelines with a therapy recommendation ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎
Included in guidelines as emerging marker
Emerging alterations, likely to be in guidelines
♦︎ Therapy recommendation
◊ Emerging marker

The Oncotype SEQ Liquid Select panel contains all alterations associated with approved therapies in NCCN guidelines for stage IV solid tumors.

HER2 Targeted Therapies EGFR Targeted Therapies Other Kinase Inhibitors PARP Inhibitor
Approved in Stage IV Solid Tumors Afatinib Lapatinib Pertuzumab Trastuzumab Ado-Trastuzumab Emtansine Afatinib Erlotinib Gefitinib Osimeritinib Cetuximab Panitumumab Ceritinib Crizotinib Dabrafenib Trametinib Vemurafenib Imatinib Cabozantinib Alectinib Oliparib
ALK ♦︎ ♦︎ ♦︎
BRCA1 ♦︎
BRCA2 ♦︎
BRAF ♦︎ ♦︎ ♦︎
EGFR† ♦︎ ♦︎ ♦︎ ♦︎ ♦︎
ERBB2 ♦︎ ♦︎ ♦︎ ♦︎ ♦︎ ♦︎
KRAS
PDGFRA‡
C-KIT‡
NRAS
MET
RET
ROS
♦︎ Marker included in FDA text associated with drug
◊ Marker associated with drug Resistance in FDA text
■ Included in Guidelines
Resistance association in Guidelines
† EGFR T790M mutation, in conjunction with a sensitizing mutation, confers resistance for EGFR tyrosine kinase inhibitors except Osimertinib, Rociletinib is under FDA review for treatment of patients with mutant EGFR non-small cell lung cancer, who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.
‡ Most alterations in PDGFRA and c-KIT are sensitive to imatinib with the exception of PDGFRA D842 and c-KIT D816V (NCCN 2017, imatinib PI). PDGFRA and c-KIT mutation testing is presently indicated for imatinib use in certain diseases other than solid tumors.

The Oncotype SEQ Liquid Select panel includes select emerging markers that are enrollment criteria for promising clinical trials.

Select Genes Currently Being Used in Clinical Trials for Stage IV Solid Tumors HER2 Targeted Therapies EGFR Inhibitors mTOR Inhibitors Other Kinase Inhibitors Anti-Hormonal Agents Androgen Receptor Targeted Therapies
ERBB2
BRAF
ROS
MET
AR
ESR1
PIK3CA
PTEN

Performance Specifications

SNVs Indels Fusions CNV (gain)
Analytical Performance* Sensitivity Level to achieve a 95% detection rate† 0.56% AF 0.19% AF 0.37% AF 2.7 copies
Lowest level detected‡ 0.1% AF 0.1% AF 0.1% AF 2.4 copies
Specificity per sample >99% >99% >99% >99%
TAT Target: 90% ≤ 14 days from receipt
Sample Requirements 2 x 10mL blood
* Demonstrated in Analytical Validation with variant positive reference cell line samples (n=105) at 30-50ng DNA input. Detection limits were selected above the Limit of Blank (LOB) corresponding to >99% per sample specificity (and >99.9999% per base specificity) among 73 cfDNA samples from 60 healthy volunteers.
† Represents mean mutant allele fraction (AF)/copies across variants tested.
‡ Lowest level tested during analytical validation. Levels lower than this may be reported.

Learn more about how Oncotype SEQ can aid treatment decisions: