Applied DNA Submits Bird Flu Test for New York State Approval

Applied DNA Sciences, Inc., a leader in PCR-based DNA technologies, has announced that its clinical laboratory subsidiary, Applied DNA Clinical Labs (ADCL), submitted a validation package to the New York State Department of Health. The package relates to a laboratory-developed test for detecting and subtyping the influenza A (H5) virus, also known as H5 bird flu.

The assay, named Linea™ Avian Influenza H5 Dx, targets both pan-influenza A and H5 bird flu. The development was spurred by growing concerns over the virus's spread and aligns with recent CDC advice recommending rapid subtyping of all influenza A-positive specimens from hospitalized patients in the U.S.

Approval from the NYSDOH would allow ADCL to offer the test across states recognizing New York's lab certifications, expanding their diagnostic service menu. The timeline for the approval process remains unclear.