Diagnostic BioSystems

Diagnostic BioSystems Inc., founded in 1994, is a Pleasanton, California-based manufacturer of immunohistochemistry (IHC) reagents and anatomic pathology products for diagnostic and research applications. The company specializes in primary antibodies (IVD and RUO formulations for U.S. and international markets), detection systems (UnoVue™ HRP, PolyVue™ Plus HRP/DAB, Mohs™ HRP), chromogens, ancillary reagents (blockers, mounting media, buffers), and antigen retrieval solutions. DBS manufactures two proprietary automated staining instruments: the DBS HighLighter™ 360 autostainer (fully automated slide staining system) and Montage Opus365™ (antigen retrieval system). The product portfolio includes fluorescent antibodies (FITC, CF488), special stains, and accessory reagents for pathology labs. Recent product launches feature cancer-specific antibodies (CEACAM5, Uroplakin 3B, Claudin 18.2, NUT1, EGFR, CD117/c-kit, PSA). The company markets products both under IVD (in vitro diagnostic) and RUO (research use only) designations, with distribution through partnerships including Cardinal Health Scientific and ThermoFisher in the USA. DBS maintains regulatory compliance with FDA and international requirements (CE, SFDA approvals noted). The company serves anatomic pathology laboratories, cancer research institutions, and clinical diagnostic centers globally through direct sales and international distributor networks.