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New modified BIOPHEN™ Factor VIII Kit

Our new assay to evaluate a chromogenic FVIII combined assay system for measuring Emicizumab and Anti-FVIII inhibitory antibodies.

The bispecific antibody Emicizumab (Hemlibra®, Roche), which has been approved in the EU since 2018, poses a new challenge for laboratories: A FVIII chromogenic assay, designed with human FIXa/FX, is available for measuring Emicizumab “FVIII like activity” in plasma. However, it cannot be used for titrating FVIII inhibitors in Emicizumab treated patients, as presence of FVIII residual activity is measured and interferes in the method.

HYPHEN BioMed now offers a solution to this problem with the variant chromogenic BIOPHEN™ Factor VIII Kit: The original BIOPHEN™ Factor VIII is designed with human FIXa and FX and can quantitatively measure Emicizumab concentrations in plasma, with high sensitivity and specificity. By replacing human FX with bovine FX, the assay turns insensitive to Emicizumab.

The combination now allows measuring Emicizumab in treated haemophiliacs (use of human FX), and to evaluate Anti-FVIII inhibitor titres in treated patients. The assays are fully automatable on all coagulation instruments.

Further information on our new modified BIOPHEN™ Factor VIII Kit is available here:

Download (HYPHEN BioMed ISTH Publikation)

Our BIOPHEN™ Factor VIII Kit is available in two different sizes:

Additional available bovine FX reagent (Product No.221402-BX)