BIOPHEN™ chromogenic activity assays and ZYMUTEST™ immunological antigen assays from HYPHEN BioMed for specific coagulation factor quantification.
BIOPHEN™ FVIII:C uses human Factor IX and Factor X reagents validated for emicizumab (Hemlibra®) activity measurement — the method of choice for FVIII monitoring in hemophilia A patients receiving emicizumab prophylaxis. A complementary bovine-FX FVIII variant assay is available for accurate endogenous FVIII measurement in emicizumab-treated patients.
Additional chromogenic assays cover FVII, FIX (including extended half-life products Alprolix®, Idelvion®, Rebinyn®), FX, FXIa, Factor VIIa (for NovoSeven® bypassing therapy monitoring), and FXIII using the isopeptidase method at 340 nm. ZYMUTEST™ antigen ELISAs are available for FVII, FIX, and FX to enable CRM-positive versus CRM-negative deficiency classification.