Quotient Receives FDA Approval

Quotient Biodiagnostics (Quotient) has received FDA approval for its biologics license application (BLA) for the first 15 monoclonal antibodies in its proprietary line of transfusion diagnostics. These products are for use by blood donor centers, reference laboratories, and hospitals to type and screen blood.

Reportedly, Quotient was formed earlier this year to directly commercialise its proprietary line of products under the tradename ALBAclone. As a result of this approval, Quotient Biodiagnostics will become the sole source of these products in the US.

The company said that the first BLA includes products used in forward blood typing, namely Anti-A, Anti-B, Anti-AB, Anti-D, Anti-E, and Anti-c, as well as some rare anti-sera including Anti-k, Anti-M, Anti-N, Anti-Le(a), Anti-Le(b), and Anti-Lu(b) – all monoclonal antibodies.

Jeremy Stackawitz, president and CEO, Quotient, said:”Our market research indicates a strong customer need for another supplier in this space, and we intend to establish Quotient as the transfusion medicine partner of choice in the US. These first products will pave the way for an innovative and comprehensive future pipeline.”