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HERNDON, Va. -- Focus Technologies announces the April 2003 availability of laboratory reagents for detecting Flavivirus (West Nile Virus) antibodies using a recombinant protein antigen licensed from the Centers for Disease Control and Prevention (CDC).
In 2002, West Nile Virus (WNV) swept through 44 U.S. states and the District of Columbia, infecting more than 4,000 people with West Nile fever and killing 274. Testing was performed mainly at public health departments and at Focus Technologies' reference laboratory in California, where more than 35,000 specimens were tested. To expand WNV testing access throughout the US, Focus Technologies will manufacture and distribute ELISA Flavivirus (WNV) reagents in 2003 to public health departments and to commercial laboratories and hospitals.
Focus will make available two different analyte specific reagent (ASR) package configurations to detect Flavivirus (West Nile) IgM and IgG antibodies. The first, an Antigen Pack, will be made available exclusively to public health laboratories as a replacement for antigen previously supplied by the CDC. The second, IgG and IgM Reagent Packs, will be sold to public health facilities and to commercial laboratories and hospitals.
Focus plans to submit a 510(k) application to the FDA for Flavivirus (West Nile) ELISA diagnostic kits once the data from formal clinical trials is complete in Summer 2003. In addition, Focus Technologies will continue to perform WNV testing in its reference laboratory using the same products now available to other laboratories. Focus also markets test kits and testing services for Arboviruses, a group of mosquito-borne pathogens found in the US that can cause encephalitis.
"We are pleased to be the first company to make available Flavivirus (WNV) ELISA ASR products to the public health community and to other laboratories," said Charles C. Harwood, Jr., CEO and president of Focus Technologies. "Our extensive experience has allowed us to respond rapidly to the current market need for high-quality reagents for this important disease."
West Nile Virus has emerged in recent years in temperate regions of Europe and North America, presenting a threat to public and animal health. The most serious manifestation of West Nile virus infection is fatal encephalitis (inflammation of the brain) in humans and horses, as well as mortality in certain domestic and wild birds. The disease is transmitted by an infected mosquito and not directly from humans or animals. The incubation period ranges from 3 to 14 days. An estimated 20 percent of people who become infected will develop West Nile fever: mild symptoms that include fever, headache, and body aches, occasionally with a skin rash on the trunk of the body and swollen lymph glands. Symptoms of mild disease will generally last a few days. Symptoms of severe disease may last several weeks, although neurological effects may be permanent. Generally, less than 1 percent of those infected develop encephalitis. Persons over 50 years of age have the highest risk of severe disease and have a higher case-fatality rate. Overall case-fatality rates in severe cases are about 10 percent. Laboratory diagnosis of WNV infection is through detection of IgM and/or IgG antibodies to WNV in serum. Positive detection of WNV IgM antibodies is confirmed using neutralization (PRNT). Viral detection using PCR is also available; PCR is highly specific but may not yield positive results at the time patients show clinical symptoms.
Focus Technologies has served the healthcare community for 25 years as an innovative developer and provider of infectious disease testing services and diagnostic products. Focus Technologies' USFDA-registered and ISO 9001-certified diagnostics manufacturing facility and reference laboratory are located in Cypress, California. Corporate headquarters and Focus' Anti-Infective Services Group, serving the pharmaceutical industry, are located in Herndon, VA.
Source: Focus Technologies