Arbor Vita 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 Arbor Vita A/H5N1 Flu Test is the first PDZ proteomics rapid test for the specific detection of H5N1. The test is highly sensitive, 100% specific, 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 Arbor Vita A/H5N1 Flu Test utilizes the Company's proprietary PDZ technology to distinguish H5N1 from seasonal influenza A infections.
In collaboration with the U.S. Naval Health Research Center in San Diego, California, Arbor Vita 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.
Arbor Vita 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 Arbor Vita 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.