Spectral Diagnostics Inc. and its joint venture research and development company, IDx Inc., announced today that its novel rapid assay for West Nile Virus (WNV) infection has met the primary endpoints of a pivotal clinical trial conducted by a major U.S. public health laboratory.

The study demonstrated that the WNV rapid assay has a high degree of sensitivity and specificity for the rapid diagnosis of WNV exposure in patients at risk.

West Nile Virus infection is a mosquito borne seasonal illness that is known to have infected tens of thousands of patients in North America since its emergence in the last several years. Many patients with West Nile Virus infection will have non-specific symptoms of fever, headache, malaise, or other flu-like symptoms that are difficult for physicians to diagnose.

According to the U.S. Centers for Disease Control about 1 in 150 patients infected with WNV will develop a serious infection such as encephalitis or meningitis which can result in paralysis or even death. West Nile Virus has caused over 400 deaths in the U.S. alone over the last 2 years and has been found in almost all U.S. states and Canadian provinces.

To date, Spectral's WNV diagnostics is the only rapid point of care test for WNV developed that is intended for individual patient by patient application at the time of their presentation to the physician.