Rapid Test Diagnoses West Nile Virus

The test has been cleared by the U.S. Food and Drug Administration (FDA) for clinical use in patients with presumptive WNV infection.

The WNV IgM STATus test was developed by Spectral Diagnostics, Inc. (Toronto, Canada). "This represents a major accomplishment for our company and is indicative of Spectral's uique capabilities in the development of novel diagnostics,” stated Dr. Paul Walker, president and CEO of Spectral Diagnostics. "This is the first test that can be used to diagnose WNV infection on an individual basis with results available in 15 minutes. Spectral's test will fill a significant unmet clinical need.”

The U.S. Centers for Disease Control and Prevention (CDC) have reported an increase of more than 34% in the number of confirmed WNV infection cases in 2006, compared to 2005. In addition, the CDC reported 135 fatalities from WV infection. Patients with WNV infection may have nonspecific symptoms of fever, headache, malaise, or other flu-like symptoms that are difficult for doctors to diagnose. Other testing practices may take a much longer time to provide clinical results, according to Spectral Diagnostics.

"This represents a major accomplishment for our company and is indicative of Spectral's unique capabilities in the development of novel diagnostics,” said Dr. Paul Walker, president and CEO of Spectral Diagnostics. "This is the first test that can be used to diagnose WNV infection on an individual basis with results available in 15 minutes. Spectral's test will fill a significant unmet clinical need.”

Spectral Diagnostics develops innovative technologies for comprehensive disease management. The company's products include a rapid diagnosis for sepsis called EAA, which has been cleared by the FDA, and other biologic reagents.



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