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FDA approves Spectral West Nile Virus test

Spectral Diagnostics has said its West Nile Virus test received marketing approval from the FDA for clinical use, sending its shares rapidly up.

Spectral’s shares nearly doubled and shot up by 95%. “We are confident that this assay will significantly improve Spectral’s growth opportunities,” stated Rob Verhagen, vice president of Business Development.

Spectral plans to make the test widely available within the US in time for the 2007 West Nile Virus (WNV) season.

The US Centers for Disease Control reported an increase of more than 34% in the number of confirmed WNV infection cases in 2006 as compared to 2005. Patients with WNV infection may have non-specific symptoms of fever, headache, malaise, or other flu-like symptoms that are difficult for physicians to diagnose. According to Spectral, other current testing practices may take considerably longer time to provide clinical results.

“This is the first test that can be used to diagnose WNV infection on an individual basis with results available in fifteen minutes. Spectral’s test will fill a significant unmet clinical need,” stated Dr Paul Walker, president and CEO.