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AVC Influenza Diagnostics
Arbor Vita Corporation received 510(k) clearance from the U.S. Food and Drug Administration in April 2009 for its rapid diagnostic test for the H5N1 influenza A viral subtype (avian or bird flu). The AVantage™ A/H5N1 Flu Test is the first PDZ proteomics rapid test for the specific detection of H5N1. The test requires no equipment or cold storage, is easy to use and gives results within 45 minutes from start to finish. These features are critical for rapid response to possible H5N1 outbreaks. The AVantage™ A/H5N1 Flu Test utilizes the company's proprietary PDZ technology to distinguish H5N1 from seasonal influenza A infections. This AVC PDZ proteomics technology is the engine that drives the high specificity and sensitivity of the test. AVC adapted PDZ proteomics to a rapid format to create this unique capability.
In collaboration with the U.S. Naval Health Research Center in San Diego, California, AVC completed a clinical trial of nearly 500 symptomatic patients that demonstrated high clinical specificity for the test. Testing at NAMRU-3 (U.S. Naval Medical Research Unit No. 3) in Cairo, Egypt demonstrated excellent sensitivity with human H5N1 culture samples.
AVC is also developing a next generation test for Flu A/Flu B (seasonal flu) that promises to be more sensitive and specific than currently available diagnostics. Using nasal and throat specimens, (rather than nasopharyngeal specimens that are unpleasant for the patient), the AVC Flu A/Flu B test is expected to provide early detection (first 2 days) of seasonal flu infections. Early detection allows timely use of antiviral drugs that work best if given in the first two days of influenza infection. |