{\rtf1\ansi\ansicpg1252\cocoartf949\cocoasubrtf430
{\fonttbl\f0\froman\fcharset0 TimesNewRomanPSMT;\f1\fswiss\fcharset0 ArialMT;}
{\margl1800\margr1600\margt500\margbl1440}
{\pard\sa900\fs50\f0\i Media Release\par}
Basel, 14 May 2007\line \line {\b Highly 
sensitive and accurate Roche HIV-1 Test approved by FDA\line } Automated test enables 
faster results for doctors monitoring treatment response\line \line Roche announced 
today that the U.S. Food & Drug Administration (FDA) has approved its new HIV-1 test for diagnostic 
use in the United States. The highly accurate Cobas AmpliPrep/Cobas TaqMan HIV-1 Test is the first fully 
automated HIV-1 diagnostic tool using real-time PCR technology in the US. It provides a broader range 
of viral load data than earlier generation tests, quantifying the amount of virus in the blood from 
very high to very low levels. With the test, labs can deliver highly accurate results faster \u8211? a decisive 
advantage for doctors monitoring how well a chosen therapy is working for the patient.\line \line "This 
approval represents a significant milestone in the automation of our virology platform in the US market", 
said Severin Schwan, CEO of Roche Diagnostics and a member of the Roche Group\u8217?s Executive Committee. 
"The new test system provides innovative options for combining a more sensitive HIV test with full 
automation that simplifies state-of-the-art molecular diagnostic testing."\line \line The 
new test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor 
the effects of antiretroviral therapy during the treatment course. One key goal of therapy is a viral 
load below the limits of detection of approved molecular diagnostic tests. Analysis of 18 trials with 
over 5,000 participants with viral load monitoring had shown a significant association between a decrease 
in plasma viremia and improved clinical outcome.\line \line According to the U.S. 
Centers for Disease Control and Prevention, each year in the US approximately 40,000 become infected 
with HIV. The agency estimates that at the end of 2003, approximately 1 million Americans were living 
with HIV/AIDS, and that approximately 300,000 more remained unaware of their HIV infections.\line \line {\b About 
the Cobas AmpliPrep/Cobas TaqMan HIV Test} \line The new test is designed for use on an 
automated platform that combines the Cobas AmpliPrep instrument for automated sample preparation and 
the Cobas TaqMan analyzer or smaller Cobas TaqMan 48 analyzer for automated real-time PCR amplification 
and detection. Configuration options also include docked instruments for \u8220?sample in/results out\u8221? testing 
that eliminates manual intervention between steps. The combined instrument platform fully automates 
the sample preparation and real-time PCR amplification and detection process for improved workflow efficiency, 
hands-off processing, and test results integrity. Each Roche test includes AmpErase\u174? enzymes designed 
to prevent cross-contamination of samples or labs.\line \line The 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. It 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. The test is not intended 
for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic 
test to confirm the presence of HIV-1 infection.\line \line {\b About 
Roche Diagnostics Virology Test Portfolio} \line Roche Molecular Diagnostics (RMD), the 
global leader in molecular diagnostics, develops tests in a broad range of areas based on the company\u8217?s 
Nobel Prize-winning PCR technology. The company\u8217?s tests for HIV-1 and Hepatitis B & C provide actionable 
health information designed to help improve disease management through diagnosis of active infections, 
quantification of the amount of virus in the blood (viral load monitoring), and identification of drug 
resistance and disease recurrence. The Cobas AmpliPrep/Cobas TaqMan HIV-1, HCV, and HBV tests have been 
available in Europe since 2005. The HIV-1 test is the first on this automated platform approved for 
use in the US. The HCV test for this platform is currently under review by the US FDA. The agency is 
also currently reviewing the Roche Diagnostics Cobas TaqMan HBV Test, which is designed for use with 
High Pure sample preparation reagents and the Cobas TaqMan 48 analyzer for automated amplification and 
detection of Hepatitis B virus in human blood. \line \line {\b About Roche 
and the Roche Diagnostics Division}  \line Headquartered in Basel, Switzerland, Roche 
is one of the world\u8217?s leading research-focused healthcare groups in the fields of pharmaceuticals and 
diagnostics. As a supplier of innovative products and services for the early detection, prevention, 
diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people\u8217?s 
health and quality of life. Roche is a world leader in diagnostics, the leading supplier of drugs for 
cancer and transplantation and a market leader in virology. In 2006 sales by the Pharmaceuticals Division 
totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. 
Roche employs roughly 75,000 people in 150 countries and has R&D agreements and strategic alliances 
with numerous partners, including majority ownership interests in Genentech and Chugai. Roche\u8217?s Diagnostics 
Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products 
and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further 
information, please visit our website www.roche.com (http://www.roche.com). \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are protected by law.\par}
{\pard \par}
{\pard\sb180\f1\fs22 {\b F. Hoffmann-La Roche Ltd}\line 4070 Basel\line Switzerland \par}
{\pard\sb180\f1\fs22 Corporate Communications\line Roche Group Media Relations \par}
{\pard\sb180\f1\fs22 Tel. +41 61 688 88 88\line Fax +41 61 688 27 75\line www.roche.com \par}
}