IncellDx

IncellDx is a molecular diagnostics and biotechnology company specializing in single-cell diagnostics for precision medicine. The company develops and manufactures diagnostic tools, reagents, probes, and antibodies for multiplex RNA in situ hybridization and protein detection. Its proprietary SUSHI (Simultaneous Ultrasensitive Signal-amplified Hybridization In Situ) platform enables simultaneous analysis of proteomic and genomic biomarkers within intact cells without complex sample preparation. Key offerings include HPV OncoTect™ kits for cervical cancer detection, mRNA probes (HPV E6/E7, CMV), monoclonal antibodies (anti-PD-L1, anti-CD45, anti-Pan Cytokeratin), hybridization core reagents, fixatives, cell cycle assays, and the incellPREP™ tissue single-cell suspension system. Products are available in multiple regulatory statuses: RUO (Research Use Only), GPR (General Purpose Reagents), ASR (Analyte Specific Reagents), CE-IVD (European In Vitro Diagnostic), and US-IVD. The company holds FDA registration, EU IVD compliance certification, and ISO 13485 quality management certification. Clinical applications target serious viral diseases including cervical cancer, HIV/AIDS, hepatitis, COVID-19, and other malignancies.