CGI Named as Thermo Fisher Companion Diagnostic Center of Excellence

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

Published on:
August 8th, 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.

“Thermo Fisher is committed to expanding its strategic alliances with organizations that share our vision of developing advanced technologies that help doctors get their patients on the right treatment quickly.” 

Joydeep Goswami, PhD, MBA, President of Clinical Next Generation Sequencing and Oncology


At CGI, we act with urgency to make the biggest impact of precision oncology to benefit patients as quickly and efficiently as possible.  In the past two years alone, CGI has launched a dozen innovative assays and technologies, as part of our “bench to bedside” mission, including liquid biopsy profiling, novel immuno-oncology flow panels, proprietary lymphoma NGS panels, etc, etc.  And, consistent with our technology-agnostic, multifaceted biomarker profiling capabilities, we’ve recently been named as part of Thermo Fisher’s Next Generation Sequencing (NGS) Companion Diagnostics (CDx) Center of Excellence Program (COEP).  This participation will allow CGI an additional strategy to help develop and commercialize NGS-based CDx testing solutions, driving usage and adoption of the novel CDx assays.

Our high-level expertise in oncology testing, global footprint, and ability to meet the stringent criteria necessary to administer clinical trials for the development and commercialization of CDx products allowed us the honor to be part of this select program.

As a preferred Thermo Fisher partner, CGI will participate in oncology-focused clinical trials in collaboration with pharmaceutical companies. CGI may also 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 further U.S. Food and Drug Administration (FDA) approvals of these tests, CGI is well-positioned to leverage its experience with the products and be among the first to offer the tests to physicians.

Beginning this month, CGI will start offering the Oncomine Dx Target Test, and will be the first laboratory in the USA to offer the test as a service to physicians, providing rapid access to this novel test. Oncomine Dx Target Test is the first next generation sequencing-based test that simultaneously screens tumor samples for multiple biomarkers associated with three FDA-approved therapies for non-small cell lung cancer. In June, the FDA granted premarket approval for the Oncomine Dx Target Test, which helps physicians match patients to targeted therapies in days instead of several weeks.

Our conversations about integrating Oncomine™ Dx Target Test into new and existing clinical trials are many. To learn more about the ways we’re integrating this and other tests into the biomarker strategies of leading clinical trials, drop me an email. You can also connect with me on LinkedIn.

 

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