FDA clears Quotient's transfusion diagnostic monoclonal antibodies
This article was originally published in Clinica
Executive Summary
The US FDA has approved a biologics licence application (BLA) for 15 monoclonal antibodies from Quotient Biodiagnostics, for use in transfusion diagnostics. The Newtown, Pennsylvania firm is developing a proprietary line of products, ALBAclone, to type and screen blood in blood donor centres, reference labs and hospitals. The BLA includes products for forward blood typing, where a patient's blood sample is mixed with serum – such as Anti-A, Anti-B and Anti-D, and some rare anti-sera including Anti-K and Anti-M. Quotient is planning further submissions to the FDA to complete its portfolio of manual reagents, including red cells for reverse typing – where a patient's serum is mixed with a known blood type – antibody screening and identification, and anti-human globulin.