Test will be made available to physicians and biopharmaceutical companies through Labcorp
OmniSeq receives New York State approval for OmniSeq INSIGHT genomic and immune profiling test. (Credit: Belova59 from Pixabay)
OmniSeq®, an innovator in next generation sequencing in oncology, today announced the New York State Department of Health’s Clinical Laboratory Evaluation Program has approved the OmniSeq INSIGHTSM test. The test detects genomic variants, genomic signatures, and immune gene expression, providing physicians with clinically actionable evidence to inform therapeutic treatment decisions and identify potential clinical trial options for patients with late-stage solid tumor cancers.
The test will be commercially available to U.S.-based clinicians exclusively through Labcorp and globally to biopharmaceutical companies through Labcorp Drug Development. Throughout Canada, the test will be available through Dynacare, a Labcorp company.
“The launch of OmniSeq INSIGHT represents the continued evolution of our commitment to innovation and to the delivery of the most advanced, comprehensive solid tumor profiling assay,” said Margot Schoenborn, Chief Executive Officer, OmniSeq. “It is designed to detect and characterize the genomic and immune features of patients’ cancer tumors to quickly guide more precise, individualized treatment decisions for patients to ensure they receive the best personalized medicine options available.”
OmniSeq INSIGHT is a tissue-based, next generation sequencing test. It has been clinically and analytically validated for all solid tumors, interrogating gene alterations that are targets identified for therapy. Completely unique to the test is the integration of immune expression profiling, which detects genes involved in the anti-cancer immune response and tumor-immune mechanisms including low-expressing genes involved in inflammatory signaling. The combined profiling of molecular and immune genes delivers an unparalleled and powerful new tool to help physicians more effectively select personalized therapies and immunotherapies, as well as match patients to clinical trials based on multi-immune marker analyses.
OmniSeq INSIGHT delivers the distinct advantage of leveraging three technologies to better inform physicians in selecting the most appropriate therapies or clinical trials for their patients. DNA sequencing is used to detect base substitutions, insertions, deletions, copy number alterations, tumor mutational burden and microsatellite instability. RNA sequencing is employed for detection of known and novel gene arrangements in order to maximize detection of fusion events and gene expression profiling; this also provides differentiating insight into critical tumor-immune interactions. Additionally, PD-L1 expression is measured by immunohistochemistry using FDA-approved assays based on the tumor type tested.
OmniSeq INSIGHT can be used in both diagnostic and drug development settings. It is actively integrated into numerous drug development programs and can be configured as an effective discovery tool, screening tool or clinical trial assay and can drive companion diagnostics development and commercialization initiatives. OmniSeq INSIGHT is offered to global biopharmaceutical customers directly and through Labcorp Drug Development, which collectively have an extensive track record in validating assays across key regulatory standards, including CLIA, CLEP, CE-IVD and FDA under an ISO 13485 quality management system for medical devices.
Source: Company Press Release