Dartmouth, Nova Scotia-based Precision BioLogic is collaborating with Roche and Genentech on the development of a new diagnostic kit for inhibitor testing of individuals with hemophilia A. The modified Nijmegen-Bethesda Assay (MNBA) screening kit was developed for broad utility for both laboratories seeking a standardized inhibitor assay for clinical management and multi-center clinical studies of patients with hemophilia A. Details about the new kit were made available via a poster presentation by both Precision and Genentech at the Thrombosis and Hemostasis 2018 Summit of North America (THSNA), held March 8-10, 2018 in San Diego, CA.
The kit includes frozen plasma samples that closely resemble samples from individuals with hemophilia A with a history of factor VIII (FVIII) inhibitors and also those from unaffected donors. The kit was developed in large part via a study that compared FVIII inhibitor values determined using the new MNBA kit with both a chromogenic assay (lab test that relies on color to signify a reaction) and a one-stage, clot-based FVIII assay. According to a recent press release, the chromogenic assay showed “superior reproducibility” compared to the one-stage clotting assay. According to study investigators, results indicated that the kit could potentially help improve the high variability in the FVIII inhibitor assay.
“Precision BioLogic has been developing, manufacturing and marketing hemostasis diagnostic products for more than 25 years,” says Paul Empey, President & CEO of Precision BioLogic. “We’re excited to expand our product offerings and make a meaningful contribution that has the potential to improve the quality of life for people with hemophilia.”
Precision BioLogic plan to commercialize the kit and pursue approval from various international regulatory authorities will start in late 2018.
Source: PRNewswire, March 13, 2018
