HERNDON, Va. - Setting a precedent in West Nile Virus testing, Focus Technologies has begun routinely supplying public health labs, commercial laboratories and large hospitals with laboratory reagents for detecting Flavivirus (West Nile Virus) antibodies. Focus' products are based on protein antigen technology licensed from the Centers for Disease Control and Prevention (CDC). To date, laboratories located in 30 states have ordered Flavivirus (West Nile Virus) reagents from Focus.
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 United States, Focus Technologies is manufacturing and distributing ELISA Flavivirus (WNV) reagents to public health departments and to commercial laboratories and large hospitals.
Today Focus markets two different analyte specific reagent (ASR) package configurations to detect Flavivirus (WNV) IgM and IgG antibodies. The first, an Antigen Pack, is being made available exclusively to public health laboratories as a replacement for antigen previously supplied by CDC. The second, IgG and IgM Reagent Packs, are being sold to public health facilities and to commercial laboratories and large hospitals. Focus plans to submit a 510(k) application to the Food and Drug Administration (FDA) for Flavivirus (WNV) 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 plans to start offering in its laboratory a confirmatory Flavivirus (WNV) plaque reduction neutralization test (PRNT) by summer 2003. In addition to Flavivirus (WNV) Focus also markets diagnostic kits and testing services for Arboviruses, a group of mosquito-borne pathogens found in the US that can cause encephalitis.
"The increased incidence of West Nile virus infections makes the availability of diagnostic testing critically important. We are pleased to provide ELISA ASR products to the public health community and to other laboratories," said Charles C. Harwood, Jr., CEO and president of Focus Technologies. "The current market requires high-quality reagents for this important disease and we are happy to apply our expertise toward the proper diagnosis of WNV on a national scale."
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). 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 the 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 must be confirmed using a plaque reduction neutralization test (PRNT) since several flaviviruses cross react with WNV. 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.