BAY 94-9027 is a Site-Specifically PEGylated B-Domain-Deleted Recombinant FVIII which has demonstrated safety and efficacy in more than 5 years of clinical studies.
Because BAY 94-9027 is a modified molecule, there is the potential for differences in performance when it is measured in certain coagulation assays established for standard FVIII products. To support medical laboratories in their the need for BAY 94-9027 assay performance information, Bayer has entered into a partnership with North American Specialized Coagulation Laboratory Association (NASCOLA) and External quality Control for Assays and Tests (ECAT) to develop BAY 94-9027 quality control samples for proficiency evaluation and further data collection on assay performance in the coagulation testing community.
The Evaluation Sample Sets contain BAY 94-9027 active pharmaceutical ingredient (API) spiked into FVIII depleted human plasma at 5 different target concentrations from 0.05 IU/mL to 1.5 IU/mL. The individual BAY 94-9027 QC sample vials are lyophilized for reconstitution with 2 mL of water prior to potency testing. Laboratories are requested to measure these samples in multiple dilutions with either ne-stage clotting assay and/or a chromogenic assay according to their regular laboratory protocol. Results and detailed information about the methodology used are returned to ECAT using a standard report form. Laboratories will receive a report after evaluation of their results.
Laboratories interested in participation in this project can obtain one Evaluation Set free-of-charge.
Instructions for testing and reporting of data are included in shipment.
To order a BAY 94-9027 Evaluation set complete to order form:
The ECAT Foundation is fully responsible for the logistics, data evaluation and reporting of the results obtained. ECAT will only share data anonymously with Bayer.