CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
July 10, 2019—Bio-Rad’s droplet digital PCR microsatellite instability research use only assay is available for early access customers. The ddPCR MSI assay can be completed in one day on a ddPCR-based platform to quantify the level of MSI present in colorectal tumors. Using either a blood or formalin-fixed, paraffin-embedded sample, the assay quantitatively identifies mutations in five loci that lead to identification of MSI status. Colorectal tumors that test positive for MSI-high are candidates for treatment with immune-checkpoint inhibitors. The assay is “simple, highly sensitive, and provides a standardized output that does not require a pathologist’s interpretation,” according to a company statement. The test can use patient blood samples in the absence of tumor tissue and does not require matched normal tissue or normal blood samples.