Alba Bioscience receives FDA license to sell additional products in the USA
Released: Thursday 19th January 2012
FOR IMMEDIATE RELEASE
Scottish Diagnostics Company Receives FDA License to Sell An Additional Range of Transfusion Diagnostic Products in the USA
Edinburgh, United Kingdom, January 19th, 2012 / -- Alba Bioscience Limited (“Alba”), the product development and manufacturing arm of Quotient Biodiagnostics Group (“Quotient”), is pleased to announce that its range of ALBAcyte® Reagent Red Blood Cell products have been licensed by the FDA for sale 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.
The range of ALBAcyte® Red Blood Cell Products licensed, including reverse cells, screening cells and both untreated and Papain-treated identification panels, are intended for use by hospitals, blood transfusion services and other healthcare institutions to test patient and donor blood samples. They 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.
“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.
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 and related reagents - Anti-A, Anti-B, Anti-AB, Anti-D and Anti-D Control;
(ii) a range of rare antisera products - including Anti-E, Anti-c, Anti-k, Anti-M, Anti-N, Anti- Lea, Anti-Leb and Anti-Lub;
(iii) the ALBAcyte® range of reagent red blood cells - including reverse cells, screening cells and both untreated and Papain-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 Hemorrhages, 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 www.quotientbd.com.
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 (“OEM Manufacturers”). Following the acquisition of Alba Bioscience in 2007, Quotient was formed in 2009 to expand Alba’s customer base beyond its historical focus on the Scottish end-user market and OEM Manufacturers.
Alba is the primary contact point for OEM Manufacturers, whilst Quotient will increasingly be the company and brand associated with end-user sales for the Group. For more details about the full range of products offered by Alba and Quotient outside of the USA, please visit our website www.albabioscience.co.uk.
Media & Technical Enquiries:
Alba Bioscience (UK)
Tel: +44 131 445 6162
Quotient Biodiagnostics (USA)
EVP, Commercial Operations
Tel: +1 919-929-3500