Below is an edited excerpt from a recent press release from Roche
Diagnostics announcing the approval.
Receives FDA Approval for a
Second-Generation Hepatitis C Viral Load Test
Another Roche FDA approval in the COBAS
TaqMan viral load portfolio
Calif. -- October 25, 2010 -- Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the U.S. Food and Drug Administration (FDA)
has approved the real-time PCR COBAS TaqMan HCV Test, v2.0.
Clinical research organizations have depended on COBAS TaqMan
technology to support hepatitis C pharmaceutical trials and
This new test will help clinicians to more confidently and effectively
monitor their patients, and to improve treatment outcomes.
"This HCV quantitative test is key to measuring the effectiveness
of many antivirals that are currently in clinical development
for the treatment of hepatitis C," said Teresa Wright,
MD, Chief Medical Officer of Roche Molecular Diagnostics. "Roche
is committed to providing complete diagnostic and treatment
solutions for this important global disease."
About COBAS TaqMan HCV Test, v2.0 For Use With High Pure System
Designed for use with the High Pure System Viral Nucleic Acid
Kit, the COBAS TaqMan HCV Test, v2.0 is intended to quantify
the amount of hepatitis C viral RNA in human plasma or serum
of HCV infected individuals. The test incorporates a manual
specimen preparation and the COBAS TaqMan 48 Analyzer for automated
amplification and detection. Roche now offers HCV viral load
test for both automated and manual specimen preparation methods;
further demonstrating Roche's commitment in providing workflow
options and flexibilities for the diverse needs of laboratories.
The test system benefits from the proven contamination controls
designed into all COBAS TaqMan assays, including built-in Roche-proprietary
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 2009, Roche
had over 80,000 employees worldwide and invested almost 10 billion
Swiss francs in R&D. The Group posted sales of 49.1 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.
Diagnostics. Roche Receives FDA Approval for a Second-Generation
Hepatitis C Viral Load Test. Press release. October 25, 2010.