FDA Approval for Rare Polyclonal Antisera Products
10 Oct 2012
Alba Bioscience Limited, a Scottish based global diagnostics company, has announced that its range of ALBAsera® Rare Antisera products have been licensed for sale by the U.S. Food and Drug Administration (FDA). The company supplies innovative and high-quality transfusion diagnostic products to the UK NHS, other Healthcare institutions worldwide and the development and manufacturing arm of Quotient Biodiagnostic Group.
"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® lines 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 in the U.S. under the ALBAclone® brand. The ALBAsera® products will be available for sale in early November.
"FDA approval of the ALBAsera products in the U.S. is a positive affirmation of the quality and science behind the product we have been manufacturing for years in the UK", said John Allan, Managing Director, Alba Bioscience. "This represents the second FDA Biologics License Applications (BLA) approval for Quotient in the U.S. this year and puts us about half way through having our complete reagent line available in the U.S."
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.
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.