CGI’s Role in the First FDA-Approved Companion Diagnostic Next Generation Sequencing Test

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

Published on:
July 10th, 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 Laboratories in the USA to Offer the 23-Gene Universal CDx Test

Thermo Fisher’s Oncomine™ Dx Target Test is the first targeted next generation sequencing (NGS) Companion Diagnostic (CDx) for non-small cell lung cancer (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.

Recognized as Thermo Fisher’s NGS CDx Center of Excellence, CGI is among the first laboratories, one of only three, in the USA to offer the Oncomine™ Dx Target Test as a service to oncologists and biopharma community at large. CGI is working with both pharmaceutical partners and clinical cancer centers to drive usage and adoption of the test.

Approved by the FDA on June 22 of 2017, this unique NGS in vitro diagnostic test (IVD) simultaneously evaluates 23 genes clinically associated with NSCLC. Following FDA approval, results from analysis of three of these genes can now be used to identify patients who may be eligible for treatment with one of the following: AstraZeneca’s EGFR inhibitor Iressa (gefitinib), Pfizer’s ALK and ROS1 inhibitor Xalkori (crizotinib), and the combination therapy of Novartis’ MEK inhibitor Mekinist (trametinib) and RAF inhibitor Tafinlar (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.

At CGI, an actionable clinical report will be ready in 5-7 days from just a few formalin-fixed, paraffin-embedded (FFPE) slides. All tests will be run on Thermo Fisher’s Ion PGM Dx System, which received FDA 510(k) clearance in parallel for use on FFPE tissue samples. The Oncomine™ Dx Target Test is a kit and requires as little as 10 nanograms of DNA from FFPE tissues samples – a critical advantage of the test, given the challenge of NSCLC patient samples often being of limited quantity.

The test report will not only indicate 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 genes associated with NSCLC that are currently investigated in clinical trials and potentially actionable in the future.

CGI has an extensive heritage in biomarker and molecular profiling for lung cancer, and we are very pleased to be able to add the Oncomine™ Dx Target Test to our comprehensive menu of cutting edge diagnostic services, as well as be one of the first 3 labs in the nation to provide rapid access to this test. Many Key Opinion Leaders (KOL) find CGI’s new offering very important nationwide:

“The Oncomine™ Dx Target Test is an important new capability for the global medical community and another significant step in the growth of CGI as an extremely qualified resource for the management of cancer patients nationwide. CGI’s 21st century molecular technologies, speed, and world-class medical environment bring increased hope to cancer patients for improved outcomes,” commented Shereen Gheith, MD, PhD, Chief of Section of Molecular Pathology and Section of Hematopathology at Health Network Laboratories.

According to Thermo Fisher, this initial approval will enable the company to work quickly to expand the test’s indications into new drug/biomarker combinations, including applications beyond lung cancer. And CGI will be in the forefront of the move…

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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