CGI Drives New Testing Paradigm for Lung Cancer with the FDA-Approved Oncomine Dx Target Test

Written by: Anna Israyelyan, MD, PhD
Manager, Biopharma Solutions

Published on:
November 2nd, 2017

Anna Israyelyan, MD, PhD
Dr. Israyelyan joined CGI in 2015. She has over 15 years of extensive cancer research and management experience in industry and academia covering wide range of medical areas, including basic, translational, and clinical research. Anna is an active member of the American Society of Hematology (ASH), the American Association for Cancer Research (AACR), and American Association for the Advancement of Science (AAAS). Dr. Israyelyan has a scientific advisory role with matrix management of scientific, technical, and operational aspects related to various biopharma projects and collaborations involving biomarkers in solid tumors and hematologic malignancies.

CGI is one of the first labs and precision medicine companies to offer Thermo Fisher’s 23-Gene Universal CDx Test

CGI has the honor of being part of Thermo Fisher’s Next Generation Sequencing (NGS) Center of Excellence Program (COEP).

As a preferred partner, CGI helps Thermo Fisher develop and commercialize NGS-based companion diagnostic (CDx) testing solutions and works with pharmaceutical partners and clinical cancer centers to drive usage and adoption of the novel CDx assays.

As you may have seen, we issued a press release this morning announcing CGI’s offering of the Oncomine Dx Target Test.  We believe this test represents a paradigm shift for how non-small cell lung cancer (NSCLC) patients are screened for targeted therapies approved by the FDA. CGI is among the first labs to offer the novel, FDA-approved 23-gene NGS test.

The test requires as little as 10 nanograms of DNA and RNA from formalin-fixed, paraffin-embedded (FFPE) tissue. This is a critical advantage of the test given that NSCLC patient samples are often limited in quantity. An actionable clinical report is ready in five to seven days from sample receipt. The report not only indicates whether patients have ROS1, EGFR, and BRAF alterations linked to the three FDA-approved treatments, but also the presence or absence of gene variants in 20 other NSCLC-associated genes.

 

About the Oncomine Dx Target Test

Oncomine Dx Target Test was approved by the FDA in June 2017 and is

the first targeted NGS-based CDx for NSCLC that simultaneously screens tumors samples for multiple biomarkers for a number of NSCLC-targeted therapies to help inform treatment decisions for NSCLC patients from one sample within a few days, eliminating the need for multiple tests. The results from analysis of three of the genes (ROS1, EGFR, and BRAF) can now be used to identify patients who may be eligible for treatment with one of the following:

  • EGFR inhibitor gefitinib,
  • ROS1 inhibitor crizotinib, and
  • the combination therapy of MEK inhibitor trametinib and RAF inhibitor dabrafenib.

With this test, physicians can now match patients to these therapies in days instead of several weeks, which it often takes when screening samples one biomarker at a time.

 

What’s next?

As a Thermo Fisher NGS Center of Excellence, CGI will continue to participate in oncology-focused clinical trials and qualify for early access to Thermo Fisher’s pipeline of novel platforms and assays to assist with development of Oncomine-branded solutions for clinical and biopharma applications. Upon FDA approval of additional tests, CGI is well-positioned to leverage its experience with the products and be the first or among the first to offer the tests to physicians and the biopharma community at large.

Check out a recently published article written about CGI’s partnership with Thermo Fisher and the Oncomine Dx Target Test here: “A Novel Partnership Takes Aim at Developing NGS Companion Diagnostics in Oncology”.

Drop me an email to learn more about integrating Oncomine Dx Target Test into your clinical trial biomarker strategy or to schedule a conversation to learn more about the assay performance! I’d be happy to schedule time to help evaluate and discuss how this panel and others on the CGI’s Lung Complete™ suite of lung cancer tests could be used to meet your clinical trial and drug development needs.

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