Navigation Links
Quotient Biodiagnostics Receives U.S. Food & Drug Administration Clearance To Enter U.S. Transfusion Diagnostics Market
Date:10/19/2009

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 customer.service@quotientbd.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.

SOURCE Quotient Biodiagnostics, Inc.


'/>"/>
SOURCE Quotient Biodiagnostics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. ImmunoVaccine Technologies Collaborates with NRC Institute for Biodiagnostics Atlantic to measure effectiveness of DepoVax(TM) with novel MRI Imagin
2. ImmunoVaccine Technologies Collaborates with NRC Institute for Biodiagnostics Atlantic to measure effectiveness of DepoVax(TM) with novel MRI Imaging
3. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
4. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
5. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
6. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
7. IsoTis Receives FDA Clearance for Accell Family of Products
8. Actavis Receives Approval of Fentanyl Transdermal System in the U.S.
9. AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
10. IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
11. XTL Receives Staff Letter From NASDAQ
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 23, 2016  Blueprint Bio, a company dedicated to ... medical community, has closed its Series A funding round, ... "We have received a commitment from Forentis ... need to meet our current goals," stated Matthew ... runway to complete validation on the current projects in ...
(Date:6/23/2016)... YORK , June 23, 2016 ... trading session at 4,833.32, down 0.22%; the Dow Jones Industrial ... S&P 500 closed at 2,085.45, down 0.17%. Stock-Callers.com has initiated ... INFI ), Nektar Therapeutics (NASDAQ: NKTR ), ... Therapeutics Inc. (NASDAQ: BIND ). Learn more about ...
(Date:6/23/2016)... (PRWEB) , ... June 23, 2016 , ... ... on quality, regulatory and technical consulting, provides a free webinar on ... on July 13, 2016 at 12pm CT at no charge. , Incomplete investigations ...
(Date:6/23/2016)... -- Amgen (NASDAQ: AMGN ) today announced a ... sciences incubator to accelerate the development of new therapies ... QB3@953 was created to help high-potential life science and ... stage organizations - access to laboratory infrastructure. ... "Amgen Golden Ticket" awards, providing each winner with one ...
Breaking Biology Technology:
(Date:6/9/2016)...  Perkotek an innovation leader in attendance control systems is proud to announce the ... employers to make sure the right employees are actually signing in, and to even ... ... ... ...
(Date:6/3/2016)... Das DOTM (Department ... hat ein 44 Millionen $-Projekt ... einschließlich Personalisierung, Registrierung und IT-Infrastruktur, an Decatur ... Implementierung von Identitätsmanagementlösungen. Zahlreiche renommierte internationale Anbieter ... aber Decatur wurde als konformste und innovativste ...
(Date:6/2/2016)... 2, 2016 Perimeter Surveillance & ... Systems, Physical Infrastructure, Support & Other Service  ... offers comprehensive analysis of the global Border ... generate revenues of $17.98 billion in 2016. ... a leader in software and hardware technologies for advanced ...
Breaking Biology News(10 mins):