FDA Approves Use of Roche Test to Screen Source Plasma for HIV, Hepatitis B Virus and Hepatitis C Virus
By Roche Molecular Systems Inc., PRNETuesday, December 1, 2009
cobas(R) TaqScreen MPX Test is the most comprehensive - detects multiple viruses for increased plasma product safety
PLEASANTON, California, December 2 - 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(R) 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(R) 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, routine NAT testing, which can detect HIV-1 and HCV
in the early stages of infection, has reduced the risk of
transfusion-transmitted HIV-1 and HCV infections to negligible levels. The
importance of hepatitis B virus in transfusion-transmitted diseases is
increasingly being recognized and NAT screening for HBV is being implemented
in some countries.
The cobas(R) TaqScreen MPX Test runs on the fully automated, real-time
PCR cobas s 201 system, designed to increase processing efficiency with a
unique modular design and ready-to-use reagents.
The cobas s 201 system has the capability of running multiple channels
using multi-dye technology, enabling simultaneous detection of several
viruses. Roche is developing another multi-dye assay on the same platform,
the cobas(R) TaqScreen DPX test, that is designed to simultaneously provide a
quantitative result for B19 virus and a qualitative result for hepatitis A
virus.
"As a stand-alone PCR system the cobas s 201 system and cobas(R)
TaqScreen MPX Test for HBV, HIV and HCV, provides a simple user interface
while improving process control and lab efficiencies," said Douglas Lee, PhD,
Sr. Director Pathogen Safety and Research, Talecris Biotherapeutics, one of
the largest fractionators in the US and a clinical trial site for the
cobas(R) TaqScreen MPX Test.
About Roche Blood Screening
Roche Diagnostics is the leading provider of real-time PCR-based nucleic
acid tests for the international blood bank market. Nucleic acid-based tests
enable earlier detection of active HIV, hepatitis C and hepatitis B
infections than conventional antibody or antigen assays. Roche assays have
been used since 1999 to screen blood and plasma products. Roche launched the
automated cobas s 201 system and the cobas(R) TaqScreen MPX Test outside the
United States in 2006 for the most comprehensive single-assay detection of
HIV-1 Groups M & O, HIV-2, and hepatitis B and C in donated blood and plasma.
The West Nile Virus test for this platform was launched in the US in 2007.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in pharmaceuticals and
diagnostics. Roche is the world's largest biotech company with truly
differentiated medicines in oncology, virology, inflammation, metabolism and
CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based
cancer diagnostics and a pioneer in diabetes management. Roche's personalized
healthcare strategy aims at providing medicines and diagnostic tools that
enable tangible improvements in the health, quality of life and survival of
patients.
In 2008, Roche had over 80,000 employees worldwide and invested almost 9
billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss
francs. Genentech, United States, is a wholly owned member of the Roche
Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more
information: www.roche.com.
All trademarks used or mentioned in this release are legally protected by
law.
Contact: Karin Bauer of Roche Molecular Systems, Inc., +1-925-730-8114
Karin Bauer of Roche Molecular Systems, Inc., +1-925-730-8114
Tags: california, Pleasanton, Roche Molecular Systems Inc., Western Europe