FDA Approves New Roche Dual-PCR Target HIV-1 Test

First dual-PCR target viral load test approved for monitoring HIV patients receiving antiretroviral therapy

PLEASANTON, California, June 4, 2010 - Roche Molecular Diagnostics (SIX: RO, ROG: OTCQX: RHHBY) announced today
that the Food and Drug Administration (FDA) approved its new dual-PCR target
HIV-1 viral load test to quantify the amount of virus in a patient's blood.
The COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) HIV-1 Test, v2.0 is the first
quantitative viral load test to amplify and detect two separate regions of a
target genome and offers a fully automated and reliable solution for
physicians to make informed treatment decisions for HIV-1 patients undergoing
antiretroviral therapy.

(Photo: photos.prnewswire.com/prnh/20100604/SF15713)

(Photo: www.newscom.com/cgi-bin/prnh/20100604/SF15713)

"With the introduction of this test, Roche is the only company in the
world to offer a dual-PCR target quantitative viral load assay," said Paul
Brown, president and CEO of Roche Molecular Diagnostics. "By virtue of its
design, the COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) HIV-1 Test, v2.0 can
improve the ability of physicians and laboratories to obtain reliable
information about HIV-infected patients in order to make informed treatment
decisions."

Highly active antiretroviral treatment (HAART) and viral load tests,
which are used to monitor the amount of human immunodeficiency virus (HIV)
circulating in blood, have contributed to a 13-year increase in life
expectancy for people infected with HIV. According to the World Health
Organization, 33 million people were living with HIV at the end of 2008. That
same year, some 2.7 million people became newly infected, and 2.0 million
died of AIDS, including 280,000 children. Roche is firmly committed to
expanding access to laboratory testing in resource-limited settings via its
humanitarian programs, such as AmpliCare and other initiatives.
(www.roche.com/programmes_in_least_developed_and_developed_countries)

"Treatment of HIV patients with new anti-viral therapies, such as
integrase inhibitors, has met with success, but can also introduce selective
pressures that result in changes to the HIV genome, which could make it
harder to detect and treat," said Tri Do, M.D., director for clinical
research and scientific affairs, Roche Molecular Diagnostics, and an
HIV-treating physician. "Roche's new dual-PCR target HIV-1 viral load test is
designed to detect current and emerging genomic variants of HIV with
increased sensitivity."

About the COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) HIV-1 Test, v2.0

The COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) HIV-1 Test, v2.0 delivers a
wide dynamic range of detection, with the ability to detect HIV-1 RNA (Group
M and O) down to 20 copies per milliliter in EDTA plasma. The test is fully
automated on the COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) System, which is in
use by over 250 laboratories in the United States for clinical viral load
testing. For improved laboratory workflow efficiency and quick turnaround
time of results to clinicians, the new HIV-1 viral load test may be run in
parallel with Hepatitis C viral load testing on the same system.

This test is intended for use in conjunction with clinical presentation
and other laboratory markers of disease progress for the clinical management
of HIV-1 infected patients. The test can be used to assess patient prognosis
by measuring the baseline HIV-1 RNA level or to monitor the effects of
antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels
during the course of antiretroviral treatment.

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 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.

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

    For more information, please contact:
    Karin Bauer
    Roche Molecular Systems
    +1-925-730-8114
    karin.bauer.kb2@roche.com

Karin Bauer of Roche Molecular Systems, +1-925-730-8114, karin.bauer.kb2 at roche.com