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 variet
'/>"/>

SOURCE Quotient Biodiagnostics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

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:3/27/2015)... March 27, 2015 WuXi PharmaTech (Cayman) ... R&D capability and technology platform company serving the ... today that an Investigational New Drug (IND) application ... rheumatoid arthritis has been accepted for review by ... In September 2012, MedImmune, the global ...
(Date:3/26/2015)... SQI Diagnostics Inc. ("SQI" or the "Company") (TSX-V: SQD; ... including the appointment of auditors, its annual and special ... "Meeting") was adjourned, as previously disclosed on March 25, ... Toronto time). The date of the ... The Meeting will reconvene at the offices of the ...
(Date:3/26/2015)... BOSTON , March 26, 2015 /PRNewswire/ ... ), a global clinical research organization ... signed a definitive agreement to acquire all ... India ("QSI"), a leading provider of specialized ... refers to the collection, detection, assessment, monitoring, ...
(Date:3/25/2015)... pharmaceutical market is one of the most ... its absolute size, plus a growing economy and increasing ... Business Monitor International. The Russian market is set to ... market, with growth estimates around 10-15% annually reaching an ... About Green Cross Green Cross provides ...
Breaking Biology Technology:Investigational New Drug Application for WuXi MedImmune's Monoclonal Antibody Accepted for Review by CFDA 2Investigational New Drug Application for WuXi MedImmune's Monoclonal Antibody Accepted for Review by CFDA 3SQI Diagnostics Inc. Announces Adjournment of Meeting 2PAREXEL Announces Execution of Definitive Agreement to Acquire Quantum Solutions India, Strengthening Leadership In Pharmacovigilance Services 2PAREXEL Announces Execution of Definitive Agreement to Acquire Quantum Solutions India, Strengthening Leadership In Pharmacovigilance Services 3PAREXEL Announces Execution of Definitive Agreement to Acquire Quantum Solutions India, Strengthening Leadership In Pharmacovigilance Services 4
... Aug. 20 Advanced Cell,Technology, Inc. (OTC Bulletin ... conditions, it plans to privately offer up to ... timing of the,closing of the offering will be ... are expected to be used to fund working ...
... CEO Mark McDade to resign for personal reasons ... BioPharma, Inc.,(PDL) (Nasdaq: PDLI ) today announced ... executive officer (CEO), Mark McDade,found no credible evidence ... by McDade to corroborate the various allegations,investigated. The ...
... Supplier Presents Today at Small Cap Financial ... ... ), a leading provider of nitinol and polymer components to the,medical device ... for the fourth fiscal,quarter ended June 30, 2007, an increase of over ...
Cached Biology Technology:Advanced Cell Technology Announces Proposed Financing 2Advanced Cell Technology Announces Proposed Financing 3PDL BioPharma Announces Internal CEO Investigation Found No Credible Evidence of Improper Personal Conduct or Breach of Fiduciary Duty 2PDL BioPharma Announces Internal CEO Investigation Found No Credible Evidence of Improper Personal Conduct or Breach of Fiduciary Duty 3PDL BioPharma Announces Internal CEO Investigation Found No Credible Evidence of Improper Personal Conduct or Breach of Fiduciary Duty 4Memry Corporation Announces Preliminary Fiscal Fourth Quarter and 2007 Revenue 2Memry Corporation Announces Preliminary Fiscal Fourth Quarter and 2007 Revenue 3Memry Corporation Announces Preliminary Fiscal Fourth Quarter and 2007 Revenue 4
(Date:3/23/2015)...  In the 2014 fiscal year, irs.gov recorded over ... figure accounts for a fraction of the estimated losses ... exceeds $11 billion globally. The polygraph has traditionally been ... occurred. Investor Mark Saint Juste along with ... partnered to administer the test in a new ...
(Date:3/20/2015)... DUBLIN , Mar. 19, 2015 Research and Markets ... the "Iris Biometrics - Global Strategic Business Report" ... worldwide markets for Iris Biometrics in US$ Thousands. The report ... , Japan , Europe ... East , and Latin America . ...
(Date:3/17/2015)...  MecklerMedia Corporation (OTCQX: MECK) announced its ... ever held in New York City ... 2015 at the Javits Convention Center. ... Acorn Product Development; Axis NJ; c-Link Systems; CoroWare; ... NewBotic Corporation; Neya Systems LLC; Reliabotics; RoboKind; RocketFarm ...
Breaking Biology News(10 mins):Polygraph Test Now Used to Protect Investors From Fraud 2Polygraph Test Now Used to Protect Investors From Fraud 3Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 2Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 3Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 4Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 5MecklerMedia's RoboUniverse New York Announces Sponsors and Exhibitors, May 11-13, 2015 2
... study, published in the March issue of Human Nature ... difference in their subjective ratings of photos of men when ... who did not have sexual partners spent more time evaluating ... No such difference was found between men who had sexual ...
... , This release is available in <A ... spread and devastating natural disaster across the globe. It ... annual damage of about 1.5 billion. The figure is ... few years (Association of British Insurers). Floods that took ...
... of environmental change? Evolvequickly. A new article in The ... new habitats developed new and advantageous traits in just a ... to look at adaptation and survival in a wild population. ... the University of California, Riverside studied 200 guppies that had ...
Cached Biology News:Single women gaze longer 2Next-generation software system for flood warning and risk analysis to be developed 2When evolution is not so slow and gradual 2
Spectrolyse (pL) PAI kit is a two-stage indirect enzymatic assay for the quantitative determination of Plasminogen Activator Inhibitor (PAI-1) activity in plasma. Sample Type: plasma...
Rabbit anti-CRSP1 (TRAP220), Polyclonal Antibody, Unconjugated Applications: Immunohistochemistry - 1:100 - 1:500...
... N-(2-Naphthoyl)-Val-phenylalaninal 2-Naphthoyl-VF-CHO White lyophilized ... GAS. A cell-permeable, reversible inhibitor of γ-secretase. ... (ED 50 = 2.6 μM) ... = 2.7 μM) in HEK293 cells stably ...
...
Biology Products: