Quotient Receives FDA License to Sell a Full Range of Reagent Red Blood Cell 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 ALBAcyte® Reagent Red Blood Cell products have been licensed for sale in the USA by the Food and Drug Administration (FDA).

“Licensing of the ALBAcyte® Reagent Red Blood Cell products by the FDA satisfies a crucial stage in the development of Quotient’s strategy to address the important US market with a full range of transfusion diagnostic products. It significantly increases the breadth of ABO testing, antibody screening and antibody identification products Quotient can now offer its key US client base” said Jeremy Stackawitz, President and CEO of Quotient.

Reagent red blood cells are used extensively for ABO testing, antibody screening and antibody identification. Quotient’s new reagent red blood cells include reverse cells, screening cells and both untreated and enzyme-treated identification panels and will join Quotient’s IgG Sensitized Red Blood Cells already on the market. All Quotient reagent red blood cell products will be sold under the ALBAcyte® brand name, and will be available for use or evaluation by the end of February 2012.

“Since entering the US market with our range of ABO Rh and rare antisera, we have been welcomed by the blood banking community who have appreciated our innovative, high-quality and cost-effective products. We are very excited to extend these same values to the seven new reagent red blood cell products now being launched and to additional products to be launched as we build our product offering further in the USA. Combined with our existing products on sale in the USA, these new products will allow Quotient to better serve its existing and future customers,” said Michael Hannan, E.V.P., Commercial Operations for Quotient.

The ALBAcyte® products join a growing line of ABO Rh reagents, rare antisera already licensed by the FDA for sale by Quotient. These include products used in ABO Rh blood typing and a range of rare antisera – all monoclonal antibodies sold under the ALBAclone® brand. Three specialty products - the ALBAclone® Advanced Partial RhD Typing Kit, Quant-Rho® FITC Anti-D Kit and our ALBAcheck® Competency Training Kit - are also on the market.

About Quotient Biodiagnostics

Quotient offers its customers the experience and expertise of a Group 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 groups. Through this expertise, it 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- Le^a, Anti-Le^b and Anti-Lu^b;

(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 Quant-Rho® FITC Anti-D Kit – which quantifies RhD Fetal Maternal Hemorrhage, without the requirement for KB staining;

(vi) the ALBAcheck® Competency Training Kit – incorporating 20 masked, positive or negative antibody samples used to train or assess staff on manual or gel testing; and

(vii) 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 http://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.