MSH2 antigen IVD, antibody

MSH2 antigen immunoassays are laboratory tests designed to detect the presence or amount of MSH2 protein in tissue samples, often used in diagnosing hereditary cancer syndromes like Lynch syndrome. Clinically, these devices help identify genetic predispositions linked to colorectal and endometrial cancers by confirming mutations in the MSH2 gene through protein expression analysis.

These devices are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820, depending on the jurisdiction. They are commonly supplied as kits for immunohistochemistry (IHC) or other immunoassay formats, intended for use in accredited pathology labs by trained professionals.