Roche Diagnostics Begins Installation of West Nile Virus Blood Screening Systems at North American Blood Centers in Preparation for Clinical Trials

PLEASANTON, Calif. -- Roche Diagnostics announces it has begun installation of its West Nile virus blood screening systems at leading North American blood centers, in preparation for clinical trials scheduled to begin on or before July 1.

The test, which uses Roche's industry-leading polymerase chain reaction technology to amplify the genetic material of West Nile virus to detectable levels, represents an important step in helping blood banks ensure the safety of blood and blood products used in transfusions and other medical procedures.

In the United States, systems were installed at two America's Blood Centers testing sites: the Gulf Coast Regional Blood Center in Houston, Texas, and the Central Florida Blood Bank in Orlando, Florida, and also at the South Bend Medical Foundation testing site in Indiana. In Canada, systems were installed at Canadian Blood Services and Hema-Quebec testing sites. Roche will continue installations of its West Nile virus systems at additional testing sites in the United States and Canada throughout May and June.

"We are very pleased with the exceptionally rapid progress Roche has made developing this nucleic-acid test for West Nile Virus," said Celso Bianco, executive vice president of America's Blood Centers, an association of locally controlled blood centers that provides almost half of the U.S. blood supply. "Roche's use of its PCR-based technology platform to automate the extraction, amplification, and detection steps have been as important to us as the company's development of the assay in time for the 2003 mosquito season. Roche's automated platform brings blood donor screening at our high-volume blood centers to a new level of sophistication, and helps us deliver our life saving blood products to hospitals and patients in a timely fashion. Roche's test represents the way of the future."

West Nile virus was first observed in the United States in 1999. In 2002, according to the Centers for Disease Control (CDC), an epidemic of more than 4,100 West Nile virus infections in the United States resulted in 284 deaths. Although mosquitoes remain the most common means of transmission of West Nile virus, the US Food and Drug Administration (FDA) and 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 2003, the US Food and Drug Administration and Centers for Disease Control last September called on industry to have a blood screening test for West Nile virus ready for the 2003 mosquito season. Canada experienced its first fatal case of West Nile virus in 2002, prompting Health Canada to include screening of donated blood as part of its national strategy to reduce the risk of West Nile virus infection.

"We designed this system to help our customers to meet the requests of their regulatory agencies on or ahead of schedule," said James Gallarda, PhD, director of blood screening at Roche Molecular Diagnostics in Pleasanton, Calif., the business area of Roche Diagnostics responsible for development of the test. "We remain committed to providing blood banks with fully automated systems that will allow them to keep up with the increasing demands of ensuring the safety of their blood supplies."

Although present in North America, West Nile virus and other members of the Japanese Encephalitis virus group are more commonly found in Africa, West Asia, the Middle East, Central America, South America and Australia.

For most individuals, infection with the virus causes no symptoms or mild flu-like symptoms that resolve in several days without harm. But for others, especially people over the age of 60 or those with compromised immune systems, these viruses can cause life-threatening medical conditions, including encephalitis (inflammation of the brain), meningitis (inflammation of the membrane around the brain and the spinal cord), or meningoencephalitis (inflammation of the brain and the membrane surrounding it).

Roche's patented polymerase chain reaction (PCR) technology, the world's leading nucleic acid amplification technology, allows minute amounts of genetic material to be amplified into billions of copies (that is, to detectable levels) in only a few hours. In addition to its applications in DNA fingerprinting and the diagnosis and monitoring of disease, PCR enables detection of infectious agents in donated blood earlier in the infection cycle, often before symptoms appear. Standard immunoassay testing, in contrast, detects evidence of a body's immune response (antibodies) later in the infection cycle, leaving an increased period of time when infections can be missed.

The majority of testing to understand the spread of West Nile virus in the United States has relied on PCR technology. Several national and state-level public health agencies use PCR-based tools to better understand the epidemiology of West Nile virus in humans and animals. Many healthcare providers and veterinary technicians rely on PCR-based tests for diagnosing the disease. Through its global licensing and scientific collaboration programs, Roche has developed and encouraged the utility of PCR technology in these and a wide variety of other areas.

Roche is the leading diagnostic provider for the international blood bank market. Roche's PCR-based AmpliNAT system, which includes a triplex assay for simultaneously detecting HIV, Hepatitis B, and Hepatitis C infections in donated blood, has been used exclusively by the Japanese Red Cross since 1999 to screen the country's entire blood supply. Roche's PCR-based AmpliScreen tests for detecting HIV and Hepatitis C in donated blood have been approved for use in the US and several other countries. Roche's AmpliScreen test for Hepatitis B is in clinical trials in the United States and is commercially available in several other countries. Roche's blood screening products are also used in countries where product registration is not required.

Source: Roche Molecular Diagnostics