Receives FDA Approval for Second-Generation
Hepatitis B Viral Load Test
viral load testing with a sensitive and fully automated
CA -- September 22, 2010 -- Roche Molecular Diagnostics
(SIX: RO, ROG; OTCQX: RHHBY) announced today that
the U.S. Food and Drug Administration (FDA) has approved
the COBAS AmpliPrep/COBAS TaqMan HBV Test v2.0 for
use in the United States. The new Roche test provides
a fully automated solution for the quantitative detection
of hepatitis B virus (HBV) DNA in human plasma or
serum for patients on HBV antiviral therapy.
new test enables clinicians to follow best practices
in patient care with standardized viral load measurements,
a broad range of detection, and high sensitivity,"
said Paul Brown, PhD, President and CEO of Roche Molecular
Diagnostics. "The system is also carefully designed
to protect the integrity of each patient result, so
clinicians can make key medical decisions about therapy
to the Centers for Disease Control, an estimated 1.2
million people in the United States are living with
chronic hepatitis B. Clinical practice guidelines
for chronic HBV highlight the importance of monitoring
the levels of circulating hepatitis B viral DNA as
an indicator of when hepatitis B therapies should
be started, and to measure response to treatment,
including suppression of HBV replication.
"Viral load testing remains the gold-standard
for the management of HBV antiviral therapy,"
said Teresa Wright, MD, Chief Medical Officer of Roche
Molecular Diagnostics. "Roche's new HBV test
provides accurate and reproducible results at the
key medical decision points, allowing the clinician
to optimize patient outcomes."
About the COBAS AmpliPrep/COBAS TaqMan HBV Test
The Roche COBAS AmpliPrep/COBAS TaqMan HBV Test v2.0
has been validated to quantify diverse samples from
genotypes A-H and pre-core mutants across a broad
linear dynamic range of 20 IU/mL to 1.7E+08 IU/mL.
The new assay uses a reduced sample input volume of
650 mcL of either serum or plasma specimens and is
standardized against the World Health Organization
(WHO) standard for hepatitis B.
This test is designed for use on Roche's fully automated
COBAS AmpliPrep/COBAS TaqMan System that is used in
more than 250 clinical laboratories across the U.S.
The platform combines the COBAS AmpliPrep Instrument
for automated sample preparation and the COBAS TaqMan
Analyzer or the smaller COBAS TaqMan 48 Analyzer for
automated real-time PCR amplification and detection.
"Sample in/results out" testing eliminates
manual intervention between steps and configuration
options allow for customizable solutions for throughput
needs. For a flexible throughput solution, the test
offers 72 tests per kit in self-sealing, ready-to-use
reagent cassettes. Roche's proprietary AmpErase enzymes
are also included in each test and are designed to
prevent cross-contamination of samples and labs.
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 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.