Cancer Genetics, Inc. is Among the First To Drive New FDA-Approved Testing Paradigm for Non-Small Cell Lung Cancer Patients by Offering Thermo Fisher Scientific’s Oncomine Dx Target Test
Published on: Thursday, November 2nd, 2017 View all Media
- Thermo Fisher’s multi-biomarker test helps match lung cancer patients to FDA-approved therapies in days instead of weeks
- CGI and Thermo Fisher are collaborating with pharmaceutical partners and clinical cancer centers to drive adoption and improve therapy selection process
- Oncomine Dx Target Test eliminates time-consuming, single-biomarker testing approach by simultaneously screening patient tumor samples for 23 genes associated with non-small cell lung cancer
RUTHERFORD, N.J., Nov. 02, 2017 (GLOBE NEWSWIRE) — Cancer Genetics, Inc. (Nasdaq:CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, announced today that it is now offering Thermo Fisher Scientific’s Oncomine Dx Target Test to physicians in an effort to lead a paradigm shift for how non-small cell lung cancer (NSCLC) patients are screened for targeted therapies that are approved by the U.S. Food and Drug Administration (FDA). CGI is one of the first laboratories and precision medicine companies globally to make the novel, FDA-approved, 23-gene test available to the medical community.
At CGI, an actionable clinical report will be ready in five to seven days using as little as 10 nanograms of DNA and RNA from formalin-fixed, paraffin-embedded (FFPE) tissue. This is a critical advantage of the Oncomine Dx Target Test given that NSCLC patient samples are often limited in quantity. The test 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 that have the potential to be immediately clinically actionable.
“We are pleased that CGI has worked diligently to make the Oncomine Dx Target Test available in short order to help physicians make informed therapy decisions for their patients right away,” said Joydeep Goswami, president of Clinical Next-Generation Sequencing and Oncology for Thermo Fisher Scientific. “Thermo Fisher shares CGI’s commitment to provide transformative products designed to help make the world healthier.”
Oncomine Dx Target Test is the first next-generation sequencing (NGS)-based test that simultaneously screens tumor samples for multiple biomarkers associated with three FDA-approved therapies for NSCLC, including the combined therapy of dabrafenib and trametinib, crizotinib, or gefitinib. In June, the FDA granted premarket approval for the test, which helps physicians match patients to targeted therapies in days instead of several weeks, eliminating the need for the time-consuming, sequential single-biomarker testing approach.
As a Thermo Fisher NGS (next generation sequencing) CDx Center of Excellence and preferred partner, CGI participates in oncology-focused clinical trials and qualifies 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 the tests, members are then well-positioned to leverage their experience with the products and be among the first to offer the tests to physicians.
“As a leading early adopter of novel tools for precision medicine, such as companion diagnostic tests, CGI continues to ensure the highest likelihood of therapy success by enabling physicians to make the best decision for their patients,” said CGI President and CEO Panna Sharma. “Oncomine Dx Target Test is an important and comprehensive tool for physicians and their lung cancer patients, allowing the best individualized care in a rapid timeframe and lower cost. We are very excited to be one of the first labs in the country to offer this important test and to continue excelling in our quest to reduce the burden of cancer among patients and improve lives broadly.”
ABOUT CANCER GENETICS
Cancer Genetics Inc. is a leader in enabling precision medicine in oncology from bench to bedside through the use of oncology biomarkers and molecular testing. CGI is developing a global footprint with locations in the US, India and China. We have established strong clinical research collaborations with major cancer centers such as Memorial Sloan Kettering, The Cleveland Clinic, Mayo Clinic, Keck School of Medicine at USC and the National Cancer Institute.
The Company offers a comprehensive range of laboratory services that provide critical genomic and biomarker information. Its state-of-the-art reference labs are CLIA-certified and CAP-accredited in the US and have licensure from several states including New York State.