Roche's new dual-target HIV-1 viral load test now available in US

      Roche's new dual-target HIV-1 viral load test now available in US

FDA-approved test enables labs to combine manual specimen preparation,
automated real-time PCR

PR Newswire

INDIANAPOLIS, Oct. 3, 2012

INDIANAPOLIS, Oct. 3, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today the U.S. availability of a new HIV-1 viral load test based on
the company's proprietary dual-target approach. The COBAS TaqMan HIV-1 Test
v2.0 for use with the High Pure System enables labs to combine an FDA-approved
process for manual specimen preparation with an automated real-time PCR
analyzer for amplification and detection.

"The availability of this new test will enable more labs, clinicians and
patients to have access to Roche's innovative HIV technology," said Whitney
Green, senior vice president, Molecular Diagnostics, for Roche Diagnostics
Corporation. "The dual-target approach is helping to improve the ability of
physicians to monitor viral load so they can effectively manage the treatment
of people living with HIV."

Approved by the U.S. Food and Drug Administration (FDA) in July, the test
utilizes the High Pure System Viral Nucleic Acid Kit for manual specimen
preparation and the COBAS TaqMan 48 Analyzer for automated amplification and
detection. It targets two highly conserved regions of the Human
Immunodeficiency Virus (HIV)-1 genome and avoids any regions which are current
drug targets, thus providing reliable test results even when mutations are

The addition of the HIV-1 Test v2.0 completes Roche's High Pure System
offering, which also provides FDA-approved processes for manual specimen
preparation for Hepatitis C and Hepatitis B testing via automated real-time
PCR. With the approval of this test, labs can consolidate HIV-1 amplification
and detection on the same platform (COBAS TaqMan 48 Analyzer) used for HCV and
HBV viral load monitoring assays for use with the High Pure System.

About the dual-target test approach

Roche's dual-target strategy for HIV-1 viral load testing optimizes the
quantification of HIV-1 subtypes by simultaneously detecting and amplifying
two separate regions of the HIV-1 genome—thus providing built-in redundancy to
minimize the effects of rare mismatches in primer/probe binding sites of a
target region. In the face of the rapidly growing genetic diversity of HIV-1
and its implications for the efficacy of antiretroviral therapy, this approach
ensures enhanced reliability of results. Since Roche first introduced this
innovative dual-target approach for monitoring HIV-1 patients on
antiretroviral therapy in 2008, more than eight million tests have been
performed worldwide.

About HIV

According to the Centers for Disease Control and Prevention (CDC), an
estimated 1.2 million persons were living with HIV infection in the United
States at the end of 2010. Of those, 20% had undiagnosed HIV infections.
Highly active antiretroviral treatment (HAART) and viral load tests that
determine the amount of circulating HIV have contributed to a profound
increase in life expectancy for people living with HIV.

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 2011, Roche had over
80,000 employees worldwide and invested over 8 billion Swiss francs in R&D.
The Group posted sales of 42.5 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: or

All trademarks used or mentioned in this release are protected by law.

For further information please contact:

Todd Siesky
Director, Corporate Communications
Roche Diagnostics Corporation
Indianapolis, IN
(317) 521-3966

SOURCE Roche Diagnostics

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