Roche announced the worldwide launch of a research product designed to detect the virus that causes Severe Acute Respiratory Syndrome (SARS). The test was developed in only eight weeks, the shortest development time ever for a research product at Roche. This was made possible in part by excellent international collaboration and networking relationships with virology institutes and government agencies, including the Genome Institute of Singapore. Roche has performed preliminary studies with the product and plans additional studies at various sites in Asia, Europe, and Canada.
Roche believes the test will be an essential research tool that will help increase understanding of the epidemiology of SARS. It is based on Roche's patented real-time polymerase chain reaction (PCR) technology, which is already used worldwide in a wide variety of clinical and research applications. The SARS research product was developed using Roche's LightCycler instrument and is designed for ease of use by technicians with a variety of training levels.
Heino von Prondzynski, head of the diagnostics division and member of the Roche Executive Committee, commented: "Even if the infection rate with the SARS virus is regressive, we do not know if we will have to face another outbreak in the future. In the meantime researchers will use our product to answer questions still open about the incubation time, the point when patients are most infectious or how long the virus can survive outside the body."
The development team was based mainly at Roche's research site in Penzberg, Germany. Supplemental work was done at outside laboratories specially designed to accommodate research involving high-risk infectious agents. Because some specimens could not be processed in Penzberg, the project team collaborated with researchers, hospitals and government agencies in the countries that represented the major SARS "hot spots."
In response to the appearance of new viral diseases, Roche Diagnostics has already set the pace for swift and proactive responses to threats from emerging pathogens. In only nine months, Roche developed a blood-screening test (investigational use only) for the detection of West Nile Virus, a mosquito-borne pathogen that can cause life-threatening illness and death and can be transmitted through infected donor blood and blood products. Roche's West Nile test is currently being evaluated at blood testing sites in the US under an Investigational New Drug (IND) application and under a similar regulatory process in Canada.
Severe Acute Respiratory Syndrome (SARS) was first reported in China's Guangdong province in late 2002. SARS is a form of atypical pneumonia caused by a new strain of coronavirus. According to the World Health Organization (Cumulative Number of Reported Probable Cases of SARS from 1 November 2002 to 10 July 2003), the disease has killed more than 800 people worldwide and infected more than 8000. The majority of infections have occurred in Asia.
Roche's patented polymerase chain reaction (PCR) technology is one of the most advanced methods in molecular diagnostics and one that earned its discoverer a Nobel Prize in Chemistry in 1993. PCR 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 nucleic acid fingerprinting and the diagnosis and monitoring of disease, PCR enables detection of infectious agents early in the infection cycle, often before symptoms appear. Standard immunoassay testing, by contrast, detects evidence of the body's immune response (antibodies) later in the infection cycle, leaving an increased period during which infections can be missed. Through its global licensing and scientific collaboration programs Roche has developed and encouraged the utility of PCR technology for a wide variety of clinical and research applications.