Cancer Genetics Inc (NASDAQ: CGIX) stock price was fairly flat after the company disclosed that it has received the New York State approval for the FDA-approved Oncomine Dx Target Test by Thermo Fisher Scientific.
The company, based in Rutherford, New Jersey, purporting to be “a leader in enabling precision medicine for oncology through molecular markers and diagnostics,” got the nod for Thermo Fisher Scientific’s Oncomine Dx Target Test from the New York State Department of Health.
The first Food and Drug Administration-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 2024
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.
Shares in CGIX gave back three cents, or 1.3%, to $1.93.
