FDA Accepts Roche Molecular Systems' Automated HIV-1 Viral Load Test Application for Review

COBAS AmpliPrep/COBAS AMPLICOR™ HIV-1 MONITOR Test, version 1.5, Uses PCR Technology to Quantify HIV-1

PLEASANTON, Cal. - February 6, 2003 - Roche Molecular Systems, Inc. (RMS) today announced that its supplement to the AMPLICOR™ HIV-1 Test, version 1.5 has been accepted for review by the U.S. Food and Drug Administration (FDA). This supplement provides data in support of the automation of the purification step using the COBAS AMPLICOR™ HIV-1 MONITOR Test, version 1.5. The COBAS AmpliPrep/COBAS AMPLICOR ™ HIV-1 MONITOR Test, version 1.5, uses polymerase chain reaction (PCR) technology to measure the amount of HIV-1 RNA (viral load) present in an infected person's blood.

HIV viral load measurement is an essential parameter used in HIV treatment decisions. The COBAS AmpliPrep/COBAS AMPLICOR HIV-1 MONITOR Test, v1.5 was designed to address the increasing needs of clinical laboratories to enhance productivity and reduce operational costs.

The COBAS AmpliPrep™ instrument automates the purification of HIV-1 RNA, together with the COBAS AMPLICOR™ instrument, which uses PCR technology to amplify and identify genetic material. This allows for accurate detection of even small amounts of viral RNA in the blood.

The test is seen as an important breakthrough in making advanced molecular diagnostic resources more affordable to operate in laboratories.

"Classical non-automated PCR methods are labor intensive. The use of the AmpliPrep and COBAS AMPLICOR instruments to automate the classic PCR process has been shown to reduce the hands-on-time of specimen preparation, amplification and detection by 60 - 80 percent," said Prof. Donald Jungkind, PhD, Director of the Clinical Microbiology Laboratory at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania, and principal investigator in early evaluations of this new assay. "Time saved by using this new system was significant and will increase overall laboratory productivity and result integrity while lowering labor costs."

Studies submitted to the FDA for review indicate that the COBAS AmpliPrep/COBAS AMPLICOR HIV-1 MONITOR Test, v 1.5, like the FDA-approved AMPLICOR HIV-1 MONITORÒ Test, version 1.5 offered by Roche, provides consistent detection of viral load levels as low as 50 copies of HIV-1 RNA per milliliter (c/mL) of plasma. This level of sensitivity is critical for optimizing treatment strategies. Maintaining an infected patient's viral load below 50 c/mL (undetectable) has been associated with a more complete and durable viral suppression.

Of equal importance, this test has the continued ability to quantitate HIV-1 Group M subtypes A-G. While HIV-1 subtype B continues to predominate in Western Countries, studies now confirm that the incidence of HIV-1 non-B subtypes is increasing all over the world. A test's ability to detect a broader range of these genetically diverse viruses will, therefore, be crucial to HIV patient care on a global basis.

"Our FDA approved viral load assays have been used for the submission of most of the new HIV drugs approved by the FDA since 1996," said Dr. Heiner Dreismann, President and CEO of Roche Molecular Systems, Inc. "We are proud to bring HIV viral load testing to the next level by offering a more automated solution which will allow laboratories to address increasing demand for such testing."

Roche is a worldwide leader in developing PCR-based diagnostic tests. The company first developed a PCR assay for HIV-1 in 1996. This fully automated assay marks Roche's fifth HIV-1 PCR product submission to the FDA.

According to the World Health Organization, more than 42 million people worldwide were living with HIV at the end of 2002, an infection rate that is expected to increase. The demand for antiretroviral therapy and consequently, viral load testing, is expected to rise accordingly. Roche Molecular Systems, Inc. provides both manual and automated HIV-1 RNA reagent kits and testing systems to laboratories throughout the world.

About Roche and the Roche Diagnostics Division

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups. The company's two core businesses in pharmaceuticals and diagnostics provide innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. The two core businesses achieved a turnover of 13.1 billion Swiss Francs in the 1st half of 2002 and employed about 57,000 employees worldwide. Roche's Diagnostics Division, the world leader in in vitro diagnostics with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services used by researchers, physicians, patients, hospitals and laboratories worldwide. For further information, please visit Roche's websites at www.roche.com and www.roche-diagnostics.com.