TORONTO, Dec. 12 /CNW/ - Spectral Diagnostics Inc. (SDI:TSX) today reports that its West Nile Virus IgM STATus(TM) Test has received marketing approval from the U.S. Food and Drug Administration (FDA) for clinical use in patients with presumptive West Nile Virus (WNV) infection.
"This represents a major accomplishment for our company and is indicative of Spectral's unique capabilities in the development of novel diagnostics," stated Dr. Paul Walker, President and CEO. "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." he added.
The U.S. Centers for Disease Control (CDC) reported an increase of more than 34% in the number of confirmed WNV infection cases in 2006 as compared to 2005. In addition, the CDC reported 135 fatalities from WNV infection. 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. Other current testing practices may take considerably longer time to provide clinical results.
"Spectral plans to make this newly FDA approved test widely available within the U.S. in time for the 2007 WNV season. We are confident that this assay will significantly improve Spectral's growth opportunities," stated Rob Verhagen, Vice President of Business Development.
Spectral is a developer of innovative technologies for comprehensive disease management. Spectral provides accurate and timely information to clinicians enabling the early initiation of appropriate and targeted therapy. Current products include Spectral's FDA approved rapid diagnostic for sepsis, the EAA(TM), the newly approved West Nile Virus IgM STATus(TM) Test, as well as a range of other biological reagents. Spectral's common shares are listed on The Toronto Stock Exchange under the symbol SDI.
Information in this news release that is not current or historically factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, the future outlook of Spectral, and anticipated events or results are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
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