Navigation Links
FDA Approves Use of Roche Test to Screen Source Plasma for HIV, Hepatitis B Virus and Hepatitis C Virus
Date:12/2/2009

PLEASANTON, Calif., Dec. 2 /PRNewswire-FirstCall/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States Food & Drug Administration (FDA) approved an additional intended use for its licensed nucleic acid test, to screen source plasma in pools comprised of up to 96 individual donations. The test, called the cobas® TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative, in-vitro test for the simultaneous, direct detection of the human immunodeficiency virus (HIV-1 Group M RNA, HIV-1 Group O RNA , HIV-2 RNA), hepatitis C virus RNA and hepatitis B virus DNA in human plasma. The test was approved in the US last year for screening plasma specimens from blood donors and, earlier this year, received the CE Mark for screening source plasma.

"Roche is committed to providing the broadest coverage and an easy-to-use menu of screening tests to ensure the highest safety of blood and plasma products," said Daniel O'Day, head of Roche Molecular Diagnostics, the business area of Roche Diagnostics that developed the test. "The expanded use of our multiplex test, which has been widely adopted and has demonstrated excellent performance worldwide, is one more step toward that goal. We are pleased to introduce this new use of the cobas® TaqScreen MPX Test in the US as we continue to further invest in solutions for this critical industry."

Human plasma is fractionated into its components, such as immunoglobulins, albumin, and clotting factors, which have many therapeutic uses. These include treatment of chronic and hereditary diseases and disorders such as hemophilia and primary immunodeficiency diseases. Plasma is also used to treat patients who have suffered severe burns or trauma, and during major surgery.

Many countries have implemented Nucleic Acid Technology (NAT) testing in order to further ensure the safety of blood and blood products. In Western Europe and North America, rou
'/>"/>

SOURCE Roche Molecular Systems, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. FDA Approves ZEGERID OTC(TM) for Over-the-Counter Treatment of Frequent Heartburn
2. FDA Approves Cymbalta(R) for Maintenance Treatment of Generalized Anxiety Disorder
3. FDA Approves Agriflu Seasonal Influenza Vaccine
4. FDA Approves Lysteda to Treat Heavy Menstrual Bleeding
5. Rogan-Delft Approves Matrox Xenia Series for Use With Zillion Suite
6. FDA approves GlaxoSmithKlines VOTRIENT(TM) for advanced renal cell cancer
7. FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use
8. FDA Approves New Treatment for Advanced Form of Kidney Cancer
9. FDA Approves Elitek(R) (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy
10. FDA Approves Cervarix, GlaxoSmithKlines Cervical Cancer Vaccine
11. U.S. Food and Drug Administration Approves CRESTOR(R) for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)...  Now that Intuitive Surgical, Inc.® has announced that ... hospitals with robotic surgery programs need to think about ... where they stand with robotic surgery. Are they performing ... adopted best practices for safety? Should they plan to ... ECRI Institute, which has nearly 50 years, experience ...
(Date:8/27/2015)... BIRMINGHAM, Ala. , Aug. 27, 2015 ... Integrated Outpatient Pharmacy Provider (IOPP™) is expanding ... launch of a medication-focused transition of care ... program, named "RxCare Management," provides hospitals with ... improve hospital performance measures that have been ...
(Date:8/27/2015)... Ohio , Aug. 27, 2015  A mere ... to Booz Allen Hamilton . A new ... product development inefficiencies are impeding and disrupting manufacturers, success. ... Cut Waste and Improve Value In Product Development Processes ... of inaccessible data and how it affects the product ...
Breaking Medicine Technology:ECRI Institute's New Robotic Surgery Service Helps Hospitals Brace for Change 2ECRI Institute's New Robotic Surgery Service Helps Hospitals Brace for Change 3Rx Care Management by Proxsys Rx - Transition of Care Technology Helps Prevent Hospital Medication Errors 2New White Paper Reveals How Manufacturers Can Improve Product Development Processes 2
(Date:8/30/2015)... ... August 30, 2015 , ... Natural Rest contains a unique mixture of ... and calming remedies, which help to improve mood disorders and anxiety. Like all other ... research in the field of regenerative medicine conducted by Dr. Amit Patel of the ...
(Date:8/29/2015)... ... ... Rio Salado College President Chris Bustamante announced on Aug. 19 the ... and Information Services. O’Shea, who has served Rio Salado for the last two and ... innovative technologies and strategies. , “I am very proud to be able to serve ...
(Date:8/29/2015)... ... August 29, 2015 , ... It can be ... against dribbled urine and sweat. "In order to prevent these problems, I conceived ... ACCESS DRYNESS ENHANCED MEN'S UNDERGARMENT provides optimal support for a male’s crotch. It ...
(Date:8/29/2015)... Viejo, CA (PRWEB) , ... August 29, 2015 , ... ... Pro X . Each preset contains 15 seconds of unique footage that users can ... that rise, fall, zoom, attract and more. Users can customize color, brightness, scale, speed, ...
(Date:8/28/2015)... ... , ... Rio Salado College joined nine educational institutions in Washington ... the EDUCAUSE - Next Generation Learning Challenges 2015 Breakthrough Models Incubator funded by the ... Models Incubator hosted by EDUCAUSE and NGLC, which is designed to bring leadership ...
Breaking Medicine News(10 mins):Health News:Creative Medical Health’s Natural Rest® Now Available on ReCreative Medical Health’s Natural Rest® Now Available on RevNutrition.com 2Health News:Rio Salado College Appoints New Vice President of Strategic Initiatives and Information Services 2Health News:Modified Men’s Underwear Promote More Comfort and Hygiene - Designed by InventHelp Client (LGI-1968) 2Health News:FCPX Effects Developer, Pixel Film Studios, Releases ProDrop Particles. 2Health News:Rio Salado College Joins 9 Educational Leaders to Reinvent Higher Learning 2Health News:Rio Salado College Joins 9 Educational Leaders to Reinvent Higher Learning 3Health News:Rio Salado College Joins 9 Educational Leaders to Reinvent Higher Learning 4
... , PHILADELPHIA (June 14, 2011) Fox Chase Cancer ... treatment institutions, today announced it has entered into an ... new program to provide next-generation sequencing analysis of solid ... the planned Cancer Genome Institute at Fox Chase, a ...
... can help college students retain and integrate new information ... research abstract that will be presented Tuesday, June 14, ... Meeting of the Associated Professional Sleep Societies LLC (APSS). ... a microeconomics test was preserved after a 12-hour period ...
... duration may contribute to the development or worsening ... a research abstract that will be presented Tuesday, ... the 25th Anniversary Meeting of the Associated Professional ... less sleep in preschool-age children significantly predicted worse ...
... cutting-edge research that promises to revolutionise the diagnosis and treatment ... used in the long-term to develop a radical new type ... dummy to meet the different needs of individual patients. If ... market within 4 years. The research is being ...
... MONDAY, June 13 (HealthDay News) -- Playing a memory-straining video ... that can be difficult to achieve through so-called cognitive training, ... ordinary video games have this kind of power. But it ... brain skills even months later, said study author Susanne M. ...
... BROOK, Ill. June 13, 2011 A ... bowel preparation are associated with relatively high adenoma ... preparation substantially decreases colonoscopy effectiveness and may mandate ... the context of suboptimal bowel preparation, of all ...
Cached Medicine News:Health News:Fox Chase Cancer Center signs agreement with Life Technologies Corp. 2Health News:Fox Chase Cancer Center signs agreement with Life Technologies Corp. 3Health News:Sleep can boost classroom performance of college students 2Health News:Sleep loss in early childhood may contribute to the development of ADHD symptoms 2Health News:New software 'hearing dummies' pave the way for tailor-made hearing aids 2Health News:New software 'hearing dummies' pave the way for tailor-made hearing aids 3Health News:Training via Video Game Shown to Boost Kids' Brain Power 2Health News:Training via Video Game Shown to Boost Kids' Brain Power 3Health News:Polyp miss rates high for colonoscopies done after poor bowel preparation 2Health News:Polyp miss rates high for colonoscopies done after poor bowel preparation 3Health News:Polyp miss rates high for colonoscopies done after poor bowel preparation 4
... is a two site sandwich ... the detection of P. falciparum ... HRP-2) and P. vivax specific ... be used for specific detection ...
The Cellabs Rapimal (P.f.) is a rapid and sensitive in vitro immunochromatography assay system for the detection of HRP-2 antigen produced by P. falciparum at the merozoite (red blood cell) stage o...
An immunochromatographic rapid test for the detection of Plasmodium falciparum in whole blood....
Malaria device / strip (3 line, P.f/P.v Ag Test-pLDH)...
Medicine Products: