FDA approves Quotient Biodiagnostics' BLA for transfusion diagnostic monoclonal antibodies

Oct 19 2009

Quotient Biodiagnostics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved 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.

Quotient Biodiagnostics was formed earlier this year to directly commercialize 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 U.S. Quotient Biodiagnostics provides innovative, high-quality and cost-effective solutions to the worldwide transfusion medicine market to help ensure safe and reliable transfusions at a reasonable cost.

"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 U.S.," said Jeremy Stackawitz, President and CEO, Quotient Biodiagnostics. "These first products will pave the way for an innovative and comprehensive future pipeline that will make our brand synonymous with quality and value, while our experienced and dedicated team provides customers with a superior service experience."

This 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. Quotient Biodiagnostics also has applications pending before, or soon to be submitted to, the FDA to complete a full portfolio of manual reagents including red cells for reverse typing, antibody screening and identification, anti-human globulin, various enhancement media, additional monoclonal and polyclonal rare-anti-sera, and a variety of controls and specialty products.