Arbor Vita, a biopharmaceutical company, has received 510(k) clearance from the FDA for its AVantage A/H5N1 flu test.
According to Arbor Vita, AVantage flu test is a non-invasive rapid diagnostic device for the specific detection of the avian influenza A/H5N1 virus in humans.
This new flu test detects the influenza virus nonstructural protein 1 in specimens from throat swabs or nose swabs collected from patients with flu symptoms, the company said.
The US Navy was an integral partner in evaluating this flu test for FDA clearance, with the Naval Health Research Center in San Diego, California providing testing on both archival and prospective clinical specimens to ensure the specificity of the test, while Navy Medical Research Unit-3 provided access to avian influenza isolates for development and testing.
Peter Lu, founder and CEO of Arbor Vita, said: 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. We are excited to receive the FDA clearance for the first rapid test to diagnose patients with this serious respiratory infection.