Quotient Biodiagnostics Receives FDA Clearance To Enter U.S. Transfusion Diagnostics Market
Published: Oct 19, 2009
NEWTOWN, Pa., Oct. 19 /PRNewswire/ -- Quotient Biodiagnostics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved its biologics license application (BLA) for the first 15 monoclonal antibodies in its proprietary line of transfusion diagnostics. These products are for use by blood donor centers, reference laboratories, and hospitals to type and screen blood.
Quotient Biodiagnostics was formed earlier this year to directly commercialize its proprietary line of products under the tradename ALBAclone®. As a result of this approval, Quotient Biodiagnostics will become the sole source of these products in the U.S. Quotient Biodiagnostics provides innovative, high-quality and cost-effective solutions to the worldwide transfusion medicine market to help ensure safe and reliable transfusions at a reasonable cost.
"Our market research indicates a strong customer need for another supplier in this space, and we intend to establish Quotient as the transfusion medicine partner of choice in the U.S.," said Jeremy Stackawitz, President and CEO, Quotient Biodiagnostics. "These first products will pave the way for an innovative and comprehensive future pipeline that will make our brand synonymous with quality and value, while our experienced and dedicated team provides customers with a superior service experience."
This first BLA includes products used in forward blood typing, namely Anti-A, Anti-B, Anti-AB, Anti-D, Anti-E, and Anti-c, as well as some rare anti-sera including Anti-k, Anti-M, Anti-N, Anti- Le(a), Anti-Le(b), and Anti-Lu(b) - all monoclonal antibodies. Quotient Biodiagnostics also has applications pending before, or soon to be submitted to, the FDA to complete a full portfolio of manual reagents including red cells for reverse typing, antibody screening and identification, anti-human globulin, various enhancement media, additional monoclonal and polyclonal rare-anti-sera, and a variety of controls and specialty products.
Those interested in learning more about Quotient Biodiagnostics and its line of products are encouraged to visit www.quotientbd.com, or call the customer service line 888-284-1901, or e-mail email@example.com.
Quotient Biodiagnostics will exhibit at the AABB Annual Meeting and TXPO, October 24 -27, 2009, in New Orleans. Attendees can meet with the company at booth #1710.
About Quotient Biodiagnostics
Quotient Biodiagnostics is the diagnostics division of Quotient Bioscience Group (United Kingdom), and through its wholly owned subsidiary, Alba Bioscience, brings over 30 years experience in the transfusion medicine market to the Group. Quotient will focus on providing innovative, high-quality and cost-effective solutions to the worldwide transfusion medicine market, helping to ensure safe and reliable blood transfusions. Quotient's goal is to develop innovative new products and technologies to serve the worldwide transfusion medicine market, build a commercial operation (initially in North America) to market and sell the Group's world leading range of blood typing and screening products and continue as an important supplier of key raw materials and innovative new products to the Original Equipment Manufacturers market.