Oncotype SEQ Liquid Select

Evidence it Works

For more than a decade physicians have trusted Oncotype DX tests from Genomic Health to individualize treatment decisions and improve outcomes for more than 750,000 cancer patients worldwide. Now, Oncotype SEQ Liquid Select builds on Genomic Health’s years of genomic expertise—leading the translation of clinical and genomic big data into actionable results for treatment selection for patients with anatomic stage IIIB and IV solid tumor NSCLC cancer.

A focus on genes included in NCCN guidelines*

Oncotype SEQ Liquid Select was designed to help you personalize treatment plans for patients who need therapy today. Instead of canvasing a wide range of genes, Oncotype SEQ Liquid Select helps identify and assess genomic alterations of 17 specific genes that have been:

  • Included in National Comprehensive Cancer Network (NCCN) guidelines,
  • Associated with sensitivity or resistance to relevant FDA-approved therapies, or
  • Established as eligibility criteria for currently enrolling Phase II-IV clinical trials.

Proven Oncotype report style

Because Oncotype SEQ Liquid Select focuses on the genes that can guide treatment options, the report is easy to interpret and share with patients. Using best practices honed on Oncotype DX reports, the Oncotype SEQ Liquid Select report is formatted specifically with treatment planning in mind. View a sample report.

Positive results from an analytical validation study

The Oncotype SEQ Liquid Select analytical validation study was developed with rigorous, best-in-class standardization and quality control in an effort to provide the most transparent and clinically meaningful performance standards. In addition, a large prospective concordance study comparing liquid and tumor tissue assessment is ongoing.

The Oncotype SEQ Liquid Select analytical validation study demonstrated positive results.1-3 It found:

  • The assay is highly sensitive, enabling consistent and reliable detection of variants at very low abundance.
  • The assay is highly specific, providing the physician and patient with confidence that a reported variant is real.
  • The assay is highly reproducible as illustrated with both cfDNA from cancer patients and assay controls.
  • Data from clinical patients support that the assay can detect genomic alterations of relevance.

The study’s authors acknowledge a lack of standardization in analytical validation of liquid biopsy assays in general—there are different definitions of sensitivity and specificity, and a limited number of very well-characterized reference samples. With Oncotype SEQ Liquid Select, the method used to establish analytical performance is directly relevant to clinical application: sensitivity is reported as the level at which a variant can be detected 95% of the time, and rather than reporting specifcity on a per-DNA base measure, it is reported on a per-sample (i.e., per patient) basis. These approaches avoid exaggerating sensitivity and specificity, providing the physician and patient with increased confidence for treatment selection.

Customer Service by phone at 866-ONCOTYPE (866-662-6897) to get the analytical validation poster handout.

Case study: Oncotype SEQ finds alterations in a 72-year-old man

Below is a case study demonstrating the ability of Oncotype SEQ Liquid Select to detect clinically relevant tumor alterations.

In this case, a 72-year-old man presented with a right upper lobe mass diagnosed as lung adenocarcinoma, with EGFR exon 21 L858R mutation detected in the diagnostic tissue core biopsy by Scorpion-ARMS PCR assay. He received afatinib with initial partial response. Tumor progression was noted five months after diagnosis. A blood sample was obtained for tumor DNA mutation analysis. The original EGFR L858R mutation was identified (at 1.3% allelic fraction) as well as a second EGFR mutation in exon 24, E967K (0.47% AF). Amplifications of EGFR, MET, and PDGFRA were also found.

Summary of Genomic Alterations and Associated Treatment Options†
Actionable in Lung Cancer Targets in Other Disease Clinical Trials
5
Genomic Alterations Reported
4
FDA Approved Therapies in This Tumor Type
5
Cited in NCCN Guidelines
1
Therapies Associated with Resistance
0
FDA Approved Therapies in Other Tumor Types
24
Potential Enrolling Trials
EGFR p.L858R afatinib
erlotnib
gefitinib
osimertinib
afatinib
afatinib/cetuximab
erlotnib
gefitinib
7 trials
EGFR p.E967K 1 trial
EGFR aplification 5 trials
MET amplification crizotinib EGFR tyrosine
kinase inhibitor
8 trials
PDGRFA amplification 4 trials
†Therapies listed in this table should be used in the context of other relevant clinical data to determine the care of the patient. It is not intended for use as a sole determinant of therapy selection and this report should not be read as a recommendation for drugs, on-or-off label. Please refer to product labeling and applicable drug package inserts for more information.
REFERENCES

1. Svedman C, et al. ESMO 2016.
2. Bergamaschi et al. AMC 2016.
3. Bergamaschi et al. AGBT 2016.

 

*NCCN Guidelines Version 3.2017 for Non-Small Cell Lung Cancer). NCCN is a registered trademark of the National Comprehensive Cancer Network. NCCN does not endorse any product or therapy.

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