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:1/15/2014)... the leading health care supply chain expertise, analytics and ... national contracts that expand its portfolio to provide hospital ... These include manufacturer product and service agreements, as well ... IT consulting support. New Novation agreements ...
(Date:1/15/2014)... , Jan. 15, 2014 Massachusetts General Hospital ... AMGN ) announced today that they have ... validate new therapeutic targets and develop novel therapies ... that affects millions worldwide. The MGH-Broad-Amgen collaboration brings ...
(Date:1/15/2014)... Texas , Jan. 15, 2014  Humberto C. Antunes,  ... Achievement Award" from the Journal of Drugs in ... & Clinical Conference (ODAC). The event is January 17-20, 2014, at ... Florida . The ODAC is ...
Breaking Medicine Technology:New Novation Information Technology VAR Contracts Offer Significant Savings to Hospitals 2Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 2Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 3Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 4Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 2Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 3Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 4
... , Rochester Medical Corporation (Nasdaq: ROCM ) will ... 2009. The Company will then hold a quarterly conference call ... 3:30 p.m. central time (4:30 p.m. eastern time). , This call ... Medical,s website at www.rocm.com . To listen ...
... Oct. 28 Qualsec (OTC Bulletin Board: QLSZ), which recently ... has been elected as a member of the Board of ... of clinical experience followed by 6 years of medical device ... and only FDA cleared RFID medical information device of its ...
Cached Medicine Technology:Rochester Medical Announces Fourth Quarter 2009 Earnings Conference Call Thursday, November 5th 2009 2VitaminSpice Appoints Dr. Richard F. Seelig as Director 2
(Date:4/18/2014)... article published online in The Gerontologist ... music is associated with a decrease in anxiety about ... of control over their lives. In particular, listening to ... about death and an increase in sense of control. ... women and men, and individuals of both low- and ...
(Date:4/18/2014)... Johns Hopkins University School of Medicine researchers have been ... for diabetes, Novo Nordisk announced this month. Of the ... and Obesity Biologics Science Forum Program, only four projects ... Hopkins researchers. They are Jonathan Powell, M.D., Ph.D.; G. ... , Jonathan Powell, a professor of oncology, will use ...
(Date:4/18/2014)... Benaroya Research Institute at Virginia Mason (BRI) recently ... molecule in metastatic breast cancer reduces both the growth ... BRI scientists have found in models of the disease ... - 80 percent and can keep the tumor from ... five-year grant comes from the National Cancer Institute of ...
(Date:4/18/2014)... A new study in the American Journal of ... searches reveals a recurring pattern that could be leveraged ... from San Diego State University, the Santa Fe Institute, ... Google searches (searches that included the term healthy and ... U.S. from 2005 to 2012. They found that on ...
(Date:4/18/2014)... by Northwestern Medicine scientists could lead to potential new ... people with scleroderma. , Fibrosis, or scarring, is ... the skin and lungs can lead to serious organ ... for new therapeutic options centers on findings made by ... identified the role that a specific protein plays in ...
Breaking Medicine News(10 mins):Health News:Religious music brings benefit to seniors' mental health 2Health News:Benaroya Research Institute evaluates immunology approach to blocking breast cancer 2Health News:New research shows people are thinking about their health early in the week 2Health News:New clues on tissue scarring in scleroderma 2
... , ... a global healthcare company, announced the official launch of its "Race with Insulin" Twitter ... Firestone Indy Lights™ race car driver Charlie Kimball, who demonstrates that with proper management, ... ...
... resource will continue to help Minnesotans find affordable medical, ... , , ST. PAUL, Minn., July 1 ... number of people without coverage for health care services, ... statewide health care information and referral service, from the ...
... FORD, Pa., July 1 Endo Pharmaceuticals (Nasdaq: ... July 30, 2009 and will host a conference call ... these results. , , David P. Holveck, ... officer, Alan Levin, chief financial officer, Ivan Gergel, M.D., executive ...
... Lack of improvement in death rates, experts say, may be ... -- Despite efforts to fine-tune the procedure for cardiopulmonary ... CPR has not changed much in recent decades, new research ... than 65 who received CPR while in the hospital survived ...
... ... ... The American Pharmacists Association (APhA) is pleased to announce the installation of its new ... Menighan was appointed as APhA,s Executive Vice President and CEO-Designate and began the transition into ...
... Network of America, LLC (DNoA) announced today the completion ... Blue Cross Blue Shield of Michigan (BCBSM), a nonprofit ... in Michigan, in addition to members of Michigan-headquartered groups ... , The acquisition brings two strategically focused companies -- ...
Cached Medicine News:Health News:Novo Nordisk Launches Twitter Page with Race Car Driver Charlie Kimball 2Health News:Novo Nordisk Launches Twitter Page with Race Car Driver Charlie Kimball 3Health News:Novo Nordisk Launches Twitter Page with Race Car Driver Charlie Kimball 4Health News:Novo Nordisk Launches Twitter Page with Race Car Driver Charlie Kimball 5Health News:Portico Healthnet Assumes Operation of 489-CARE Information and Referral Service 2Health News:Endo Pharmaceuticals to Announce Second Quarter 2009 Financial Results on July 30, 2009 2Health News:CPR Survival Rates for Older People Unchanged 2Health News:CPR Survival Rates for Older People Unchanged 3Health News:APhA Welcomes New Leader 2Health News:APhA Welcomes New Leader 3Health News:Dental Network of America (DNoA) Acquires DenteMax, Owned by Blue Cross Blue Shield of Michigan 2Health News:Dental Network of America (DNoA) Acquires DenteMax, Owned by Blue Cross Blue Shield of Michigan 3Health News:Dental Network of America (DNoA) Acquires DenteMax, Owned by Blue Cross Blue Shield of Michigan 4
SOLOS Endoscopy shares your commitment to provide every patient with the highest quality care available through our ongoing research and development of advanced surgical instruments and diagnostic so...
SOLOS Endoscopy shares your commitment to provide every patient with the highest quality care available through our ongoing research and development of advanced surgical instruments and diagnostic so...
SOLOS Endoscopy shares your commitment to provide every patient with the highest quality care available through our ongoing research and development of advanced surgical instruments and diagnostic so...
... 5mm AEM Laparoscopic Instruments incorporate a layered ... are shielded and monitored to prevent stray ... instrument caused by insulation failure or capacitive ... protective shield built into all AEM Instruments ...
Medicine Products: