Arbor Vita Corporation (AVC), a biopharmaceutical company developing both diagnostics and therapeutics, has received 510(k) clearance from the US Food and Drug Administration for its AVantage A/H5N1 Flu Test. This is a non-invasive rapid diagnostic device for the specific detection of the avian influenza A/H5N1 virus in humans. AVC's AVantage A/H5N1 Flu Test detects the influenza virus non-structural protein 1 (NS1) in specimens from throat swabs or nose swabs collected from patients with flu symptoms.
"We applaud the FDA's efforts to foster fast, early identification of the avian influenza A/H5N1 virus in humans. Rapid, early detection of avian influenza is paramount to early treatment and containment of a deadly disease with pandemic potential," said Peter S Lu, founder and chief executive officer of Arbor Vita Corporation. "We are excited to receive FDA clearance for the first rapid test to diagnose patients with this serious respiratory infection."
While the AVantage flu test is highly sophisticated, it is easy-to-use. It is a rapid test that can detect the presence of the avian influenza A/H5N1 virus in less than 40 minutes, without complicated sample preparation.
The US Navy was an integral partner in evaluating this flu test for FDA clearance, with the Naval Health Research Center (NHRC) in San Diego, CA providing testing on both archival and prospective clinical specimens to ensure the specificity of the test, while Navy Medical Research Unit-3 (NAMRU-3) provided invaluable access to avian influenza isolates for development and testing.
"This new rapid test will provide an extra level of protection for not only the general U.S. population, but for our forward-deployed troops in areas with avian influenza activity," commented Dennis Faix, commander, NHRC.
Christopher A Myers, Laboratory director, Department of Respiratory Diseases Research, NHRC continued, "This test can help detect an isolated case or outbreak in an austere environment, allowing for the rapid, targeted interventions necessary if we hope to contain or slow an avian influenza outbreak."
The AVantage A/H5N1 Flu Test is the first rapid diagnostic device that will be used to detect the H5N1 virus strain from throat swabs or nose swabs collected from patients with flu symptoms. In studies conducted in collaboration with NHRC and NAMRU-3, the AVC flu test demonstrated exceptional sensitivity and specificity for the H5N1 subtype of influenza A. The AVC flu test utilizes the company's proprietary PDZ protein technology to uniquely detect the virulence factor NS1 protein from A/H5N1 viruses, which accounts for the excellent sensitivity and specificity of this diagnostic device.
Naval Health Research Center (NHRC) serves as a leading research and development laboratory for the Department of Defense.
Arbor Vita is a biopharmaceutical company pioneering the discovery, development and commercialization of novel drugs and diagnostics through a new family of targets-PDZ proteins.