FDA licenses Quotient’s ALBAsera products

Quotient Biodiagnostics, Inc. ("Quotient"), a supplier of innovative and high-quality transfusion diagnostic products to hospitals, blood banks and other healthcare institutions, is pleased to announce that its range of ALBAsera® Rare Antisera products have been licensed for sale by the U.S. Food and Drug Administration (FDA).

"The licensing of the ALBAsera® rare antisera products by the FDA is yet another important milestone achieved by Quotient this year", said Jeremy Stackawitz, President and CEO of Quotient. "The launch of these products allows us to better meet our customers' needs and advances our progress towards being the premier provider of manual transfusion diagnostics products in the U.S."

Rare antisera are used by hospital blood banks and reference laboratories to confirm the presence of specific antigens on donors' or patients' red blood cells helping to ensure the right blood is given to the right patient, thus avoiding significant transfusion reactions. The ALBAsera® line of products are polyclonal reagents and are derived from human blood donations. These products join an existing suite of monoclonal rare antisera already on the market under the ALBAclone® brand. The ALBAsera® products will be available for sale in early November 2012.

"This approval is particularly important as some of the products included in the approval, such as Anti-s, Anti-Fy^b, and Anti-Wr^a, are frequently out of stock or simply not offered by the other suppliers on the market", said Michael Hannan, E.V.P., Commercial Operations for Quotient. "The timing of the approval is perfect as AABB, our industry's largest meeting, starts this Saturday, so people can stop by our booth (#431) to learn more."

Approval of the ALBAsera® products expands Quotient's already licensed U.S. portfolio to nearly 40 products. This portfolio includes products used in ABO Rh blood typing and a range of monoclonal rare antisera sold under the ALBAclone® brand; reagent red blood cell products sold under the ALBAcyte® brand; enhancement media sold under the ALBAhance® brand; and, two specialty products - the ALBAclone® Advanced Partial RhD Typing Kit and our ALBAcheck® Competency Training Kit.