Alba Bioscience to Market Transfusion Products in the US

Alba Bioscience Limited, the product development and manufacturing arm of Quotient Biodiagnostics Group, has announced that its range of ALBAcyte^® Reagent Red Blood Cell products have been licensed by the FDA for sale in the US.

The ALBAcyte^® Red Blood Cell Products range includes reverse cells, screening cells and both untreated and Papain-treated identification panels. The products are intended for use by hospitals, blood transfusion services and other healthcare institutions to test patient and donor blood samples. The products will be available for sale from Quotient in the USA from February 2012 and will join the ALBAcyte^® IgG Sensitized Red Blood Cells and ALBAclone^® monoclonal antisera, which have already been licensed by the FDA for use in the USA.

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

“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 and 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 are also available for sale in the USA by Quotient - the ALBAclone^® Advanced Partial RhD Typing Kit, Quant-Rho^® FITC Anti-D Kit and our ALBAcheck^® Competency Training Kit.

A full range of transfusion diagnostic products are also available for sale from Alba for use in hospitals, blood transfusion services and other healthcare institutions in the United Kingdom (UK) and elsewhere in Europe. Alba’s products comply with strict guidelines as defined by Directive 98/79/EC on the use of in vitro Diagnostic Medical Devices and the recommendations contained in the Guidelines for Blood Transfusion Services in the UK.