Cancer Genetics Receives New York State Approval for FDA-Approved Oncomine Dx Target Test by Thermo Fisher Scientific

Cancer Genetics, Inc. (Nasdaq:CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, today announced it has received approval for Thermo Fisher Scientific’s Oncomine Dx Target Test from the New York State Department of Health. The first FDA-approved test of its kind, the Oncomine Dx Target Test is playing an increasingly important role in lung cancer diagnostics, a market that is projected to reach $3.65 billion by 2024i.The Oncomine Dx Target Test is a next-generation sequencing (NGS)-based companion diagnostic (CDx) that simultaneously screens tumor samples for multiple biomarkers associated with three FDA-approved therapies for non-small cell lung cancer (NSCLC), including the combined therapy of dabrafenib and trametinib, crizotinib, or gefitinib.“We applaud CGI’s focused efforts in making available and now gaining approval from the New York State Department of Health for Oncomine Dx Target Test,” said Joydeep Goswami, president of Clinical Next-Generation Sequencing and Oncology for Thermo Fisher Scientific.CGI was one of the first laboratories in the country to make the novel 23-gene test available to the medical community. The Oncomine Dx Target Test helps physicians match patients to targeted therapies in days rather than weeks, eliminating the need for a time-consuming, sequential single-biomarker testing approach.At CGI, a report for the Oncomine Dx Target Test is 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 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 (crizotinib, gefitinib, dabrafenib and trametinib, respectively), but also the presence or absence of gene variants in 20 other NSCLC-associated genes.“CGI was one of the first laboratories and precision medicine companies in the country to offer the Oncomine Dx Target Test, and now it is the first and only laboratory to offer it in the State of New York,” said Panna Sharma, CGI President and CEO. “This approval not only underscores CGI’s commitment to providing NGS panels that meet the highest quality of standards, but it also marks an important step for the company as we continue to serve a major market with considerable runway for growth as it is projected to reach $3.65 billion over the next six years.” As a Thermo Fisher NGS CDx Center of Excellence Program member, CGI participates in oncology-focused clinical trials. It also 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 well-positioned to leverage their experience with the products and to be among the first to offer the tests to physicians.



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