Focus Submits West Nile Virus Diagnostic Kits to FDA for 510(k) Clearance

HERNDON, Va. -- Focus Technologies announces that it has completed clinical trials on its West Nile Virus (WNV) IgG and IgM ELISA diagnostic kits and has filed a 510(k) application with FDA. This is an important development as there are currently no West Nile Virus FDA-cleared kits on the U.S. market. Focus' products are based on protein antibody technology licensed from the Centers for Disease Control and Prevention (CDC).

Experts believe that 2003 could be a heavy season for West Nile Virus cases in the U.S. According to CDC, 294 people died of the disease in 2002 and there were over 4,000 confirmed cases. Last year, testing was performed mainly at public health departments and at Focus Technologies' reference laboratory in California. Focus alone tested over 35,000 specimens. To expand access to WNV testing throughout the U.S., Focus Technologies began offering in April of this year analyte specific reagent (ASR) products to public health departments, commercial laboratories and major hospitals. Today Focus continues to perform testing for WNV in its reference laboratory in Cypress, California using the same ASR products now available to other laboratories.

"We are eager to receive marketing clearance on our WNV ELISA kits so that more facilities in the U.S. will be able to conduct testing for this important disease during the 2003 season," said Charles C. Harwood, Jr., CEO and president of Focus Technologies. "We are pleased that our extensive experience with West Nile Virus and other vector-borne diseases has allowed us to respond rapidly to this public health concern."

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% of the people who become infected will develop West Nile fever: mild symptoms 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% 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. Viral detection using PCR is also available. PCR is highly specific but may not yield positive results at the time patients show clinical symptoms.

Source: Focus Technologies