OmniSeq Receives New York State Approval for Cancer Genomic, Immune Profiling Test

OmniSeq said on Tuesday that it has received approval from the New York State Department of Health’s Clinical Laboratory Evaluation Program for its Insight cancer genomic and immune profiling test.

With the approval, the test, which detects genomic variants, genomic signatures, and immune gene expression to inform cancer treatment decisions, will be available to patients in New York.

OmniSeq will make the test available in the US exclusively through Labcorp and will sell it globally to biopharma companies through Labcorp Drug Development. In Canada, Dynacare, a Labcorp company, will be the exclusive provider of the test. OmniSeq and Labcorp signed an exclusive distribution agreement for OmniSeq’s tests in 2017 and expanded it in 2019.

“The launch of OmniSeq Insight represents the continued evolution of OmniSeq’s commitment to innovation and to delivering the most advanced, comprehensive solid tumor profiling assay. It is designed to detect and characterize the genomic and immune features of cancer to quickly guide more precise, individualized treatment decisions for patients with solid tumor cancers,” OmniSeq CEO Margot Schoenborn said in a statement.

Source: https://www.genomeweb.com/regulatory-news-fda-approvals/omniseq-receives-new-york-state-approval-cancer-genomic-immune