Quotient Receives FDA License to Sell a Range of Rare Polyclonal Antisera Products in the USA

NEWTOWN, Pa.--(BUSINESS WIRE)-- 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-Fyb, and Anti-Wra, 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.

About Quotient Biodiagnostics

Quotient offers its customers the experience and expertise gained from more than 30 years of product development, manufacturing, sales and distribution of transfusion diagnostic products worldwide, both directly to end users or via other major transfusion diagnostics suppliers. Quotient is focused on providing innovative, high-quality and cost effective products to the transfusion diagnostics market, helping to ensure safe and reliable blood transfusions worldwide.

Quotient is able to offer hospitals, blood banks and other health care institutions across the USA a comprehensive range of products, including:

(i) ABO Rh blood typing reagents - Anti-A, Anti-B, Anti-AB and Anti-D;

(ii) a range of rare antisera products - including Anti-E, Anti-c, Anti-k, Anti-M, Anti-N, Anti- Lea, Anti-Leb, Anti-Lub; and now, Anti-s, Anti-Fya, Anti-Fyb, Anti-Wra, and Anti-K;

(iii) the ALBAcyte® range of reagent red blood cells - including reverse cells, screening cells and both untreated and enzyme-treated identification panels;

(iv) the ALBAclone® Advanced Partial RhD Typing Kit - which identifies weak and partial RhD types with results comparable to molecular analysis, but at a fraction of the cost;

(v) the ALBAcheck® Competency Training Kit – a kit which incorporates masked, positive or negative antibody samples to train or assess staff on manual or gel testing; and

(vi) enhancement media and other specialty products.

In addition to the above products, Quotient has nearly as many products in its development pipeline, either submitted to the FDA for licensing or in preparation for submission.

For more details about the full range of products offered by Quotient in the USA, please visit our website www.quotientbd.com.

Based in Scotland, Alba Bioscience is the product development and manufacturing arm of Quotient. As well as developing and supplying innovative products for sale by Quotient, Alba has a successful record of developing and manufacturing products for other major transfusion diagnostics groups. For more details about the full range of products offered by Alba and Quotient outside of the USA, please visit our website http://www.albabioscience.co.uk.

Quotient Biodiagnostics, Inc.
Michael Hannan, 919-929-3500

Source: Quotient Biodiagnostics, Inc.