Business Wire - Wednesday March 3, 1999

This test is now the most sensitive means to measure levels of HIV circulating in an infected person's blood ("viral load"). The test can measure levels previously considered "undetectable" --down to 50 copies per milliliter of plasma.

The approval is considered a significant advance in the battle against HIV. Published studies indicate that lowering plasma HIV RNA to below 50 copies/mL is associated with a more complete and durable viral suppression. Physicians will now have a clearer picture of therapeutic effectiveness against the HIV virus. Since the AMPLICOR HIV-1 MONITOR UltraSensitive Method was made available for research use in new drug studies in early 1997, it has become the test of choice in pharmaceutical drug trials designed to demonstrate the efficacy of antiretroviral therapy.

This is, in part, a reflection of current thoughts about HIV-1 infection, that is, no virus is tolerable and the goal of optimal antiretroviral therapy is to drive levels as low as possible for as long as possible.

"This is an important achievement in the area of HIV diagnosis and treatment, because having highly accurate information on the status of the virus is the foundation on which all treatment and wellness regimens are built," said Tadd Lazarus, MD, an AIDS-treating physician and director of medical affairs for Roche Diagnostics.

"The role of plasma HIV RNA testing is firmly established -- in conjunction with CD4 testing -- as the key indicator of success with HAART (Highly Active AntiRetroviral Therapy)."

PCR Innovation Dramatically Impacts HIV Treatment

The AMPLICOR HIV-1 MONITOR UltraSensitive Method is based on Nobel Prize winning polymerase chain reaction (PCR) technology. PCR allows the amplification and identification of specific DNA or RNA sequences from a patient blood sample. Because PCR can directly detect the presence of a virus in a person's genetic material, it has emerged as the "gold standard" in managing infectious diseases like HIV/AIDS and hepatitis. HIV-1 viral load is measured to assess an infected individual's disease prognosis and response to drug therapy.

Roche Diagnostics received FDA approval for the first HIV viral load test -- the AMPLICOR HIV-1 MONITOR(TM) Test -- in June 1996. This test is capable of measuring the amount of active HIV in a person's bloodstream across a dynamic range of 400 to 750,000 copies of HIV-1 RNA per milliliter of plasma.

The new AMPLICOR HIV-1 MONITOR UltraSensitive Method can measure viral load across a dynamic range of 50 to 75,000 copies of HIV-1 RNA per milliliter of plasma. Clinical studies were performed at the University of New Mexico, Johns Hopkins Hospital in Baltimore, and the Cleveland Clinic.

Patient Advocates Press for Greater Access

"Using the UltraSensitive test is crucial to managing the effectiveness of treatment, detecting treatment failure, monitoring the success of treatment over the long run, and indirectly measuring the potential for a person's immune restoration," said Jules Levin, executive director of the National AIDS Treatment Advocacy Project (NATAP).

"People with the AIDS virus need access to this test to help them make the best treatment decisions. That's why it's urgent that private and public insurers reimburse this as soon as possible."

To facilitate further access to the AMPLICOR HIV-1 MONITOR UltraSensitive Method, Roche has expanded its "AMPLICOR Patient Assistance Program" to incorporate this new test. Established in June 1996 when the company's first PCR-based HIV test was approved by the FDA, this program provides free testing to patients who have a demonstrated financial need.

The program also provides reimbursement assistance to patients, their providers, and testing laboratories. They can obtain information on this program by calling 888/TEST-PCR (888/837-8727).

Automated Testing

With the FDA approval of its AMPLICOR HIV-1 MONITOR UltraSensitive Method, Roche plans to incorporate this high sensitivity into all future HIV-1 MONITOR tests, including the COBAS AMPLICOR(TM) system. COBAS AMPLICOR(TM) is an automated bench-top analyzer that allows clinical laboratories to perform infectious disease testing on PCR-ready specimens. It performs both amplification and detection, and is the first automated system with this capability.

About Roche

The Roche Group is a world leader in research-based healthcare with principal businesses in pharmaceuticals, diagnostics, vitamins, fragrances, and flavours. Through the company's Diagnostics Division, innovative testing products and services are made available to physicians, patients, hospitals and laboratories worldwide.

The Diagnostics Division is composed of four business units: Roche Molecular Biochemicals, Roche Molecular Systems, Roche Laboratory Systems and Roche Patient Care. Roche Molecular Systems, Inc., is responsible for the research, development, manufacture, and marketing of PCR-based products under the trade name AMPLICOR.

Contact: Roche Diagnostics Paula Evangelista, 908/253-7660
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