Sponsor: OmniSeq
Roswell Park Comprehensive Cancer Center subsidiary OmniSeq and LabCorp jointly launched OmniSeq Advance, a single test that combines targeted therapy and immuno-oncology biomarkers. The test is the first New York State CLEP-approved assay to combine next-generation sequencing (NGS)-based comprehensive genomic profiling, tumor mutational burden (TMB) and microsatellite status (MSI), PD-L1 and CD8 proteins by immunohistochemistry (IHC), and RNA-sequencing gene expression profiling (GEP) of the tumor microenvironment from FFPE patient samples. The company projects that the OmniSeq Advance test will report clinically actionable results for 99% of tested patients. For non-small cell lung cancer (NSCLC), physicians can test for KRAS, EGFR, ALK, PD-L1, TMB, and MSI status, as well as test for rarer mutations in BRAF, RET, ROS, MET, and NTRK. OmniSeq projects more than 80% of NSCLC samples will produce Level 1 or 2 evidence, as defined by the FDA’s “CDRH’s Approach to Tumor Profiling Next Generation Sequencing Tests” Fact Sheet.
