Roche Diagnostics Receives FDA Authorization to Begin Clinical Trials for TaqScreen West Nile Virus Test

PLEASANTON, Calif. -- Roche Diagnostics, the world's leading provider of nucleic acid-based blood screening products, announced today that it has received authorization from the United States Food & Drug Administration (FDA) to begin clinical trials of the TaqScreen West Nile Virus Test, the first PCR-based nucleic acid system to fully automate the specimen processing, amplification, and detection steps in blood screening. Roche created the test in record time to address concerns expressed by the FDA and Centers for Disease Control and Prevention (CDC) last September about the potential for an increase in transfusion-related West Nile Virus infections during the 2003 mosquito season.

To date, Roche is the only company to receive FDA authorization to begin screening newly donated blood (versus archived samples) at U.S. blood centers. As part of the clinical trial, samples of all blood donated at participating blood centers will be tested for West Nile virus. As part of its non-clinical studies, Roche will also include testing of archived blood samples.

The company's clinical trials are scheduled to begin in the United States and Canada (where Roche has filed a separate clinical trial application) on or before July 1. Eleven blood testing laboratories will screen samples from a network of nearly 100 local donation centers across the United States, including Alaska and Hawaii.

"We appreciate the confidence that the FDA has expressed in the platform and assay data submitted with our Investigational New Drug application," said Richard Thayer, vice president of blood screening at Roche Molecular Diagnostics, the business area of Roche Diagnostics responsible for developing the test. "Results from our non-clinical studies as well as preliminary feedback from customers give us every confidence that our test will perform well in screening newly donated blood."

Roche's non-clinical studies have also shown that, in addition to West Nile virus (Kunjin and New York strains), its test can detect other potentially deadly members of the Japanese Encephalitis virus group, including St. Louis Encephalitis virus, Japanese Encephalitis virus, and Murray Valley Encephalitis virus. A subset of the blood donations that test positive in the company's trials for West Nile virus will be sent for further laboratory testing to determine the specific member of the Japanese Encephalitis group virus infecting the blood.

"We fully expect that our TaqScreen West Nile Virus Test will be a valuable tool for North American blood banks working hard to ensure the safety of their blood supplies," said Heiner Dreismann, PhD, head of Roche Molecular Diagnostics. "This test is further evidence of our ongoing commitment to providing fully automated, next-generation products to the international blood screening community."

West Nile virus was first observed in the United States in 1999. In 2002, an epidemic of more than 4,100 West Nile virus infections in the United States resulted in 277 deaths. In previous years, before nucleic acid-based blood screening was available, the US also experienced periodic epidemics of St. Louis Encephalitis virus, primarily in the Gulf Coast and Mississippi Valley regions of the country.

For most people, infection with West Nile virus causes no symptoms, or only mild flu-like symptoms (called West Nile fever). In a small percentage of those infected, however, especially the elderly or those with compromised immune systems, infection can progress to serious, life threatening illnesses, including swelling of the brain (encephalitis), the brain and the membrane surrounding it (meningoencephalitis), or the membrane around the brain and spinal cord (meningitis).

Although mosquitoes remain the most common means of transmission of these viruses, the United States Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) last year indicated that a small number of West Nile virus cases had likely spread through blood transfusions and tissue donations. Because incidence of infection with West Nile virus is expected to increase in North America in 2003, the FDA and CDC last September called on industry to have a blood screening test for West Nile virus ready for the 2003 mosquito season. In 2002, after outbreaks of West Nile Virus in Canada, Canadian health authorities issued a request to its blood banks to begin screening in 2003.

Source: Roche Diagnostics