Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA or the "Company"), a leader in PCR-based DNA technologies, today announced that Applied DNA Clinical Labs (ADCL), the Company's wholly-owned clinical laboratory subsidiary, has submitted a validation package to the New York State Department of Health (NYSDOH) to request approval as a laboratory-developed test (LDT) for a PCR-based assay for the detection and subtyping of influenza A (H5) virus, also known as H5 bird flu, highly pathogenic avian influenza, or H5N1 (collectively "H5 bird flu"). ADCL's Linea™ Avian Influenza H5 Dx assay ("AIH5 Dx") is a highly sensitive, multi-target diagnostic assay capable of detecting and discriminating between pan-influenza A and H5 bird flu. The timeline for NYSDOH's review of the Company's validation package is unknown, as is whether such approval will be granted.
Development of AIH5 Dx was initiated in January 2025 amid escalating concerns over the spread of the H5 bird flu virus in dairy cows and poultry and several human cases of infection in U.S. dairy and poultry workers, as well as a health advisory published by the Centers for Disease Control and Prevention (CDC) recommending the rapid subtyping of all influenza A-positive specimens from hospitalized patients. If approved, ADCL will launch an H5 bird flu testing service to accept samples originating in all U.S. states that recognize New York's CLEP/CLIA certification, enabling physicians to order the test for patients suspected of infection.
Patient samples would be sent to, and testing would be undertaken at, ADCL, an NYSDOH CLEP-permitted, CLIA-certified (Clinical Laboratory Improvement Amendments) laboratory currently permitted for virology and genetics (molecular). If approved, the testing service would be added to ADCL's diagnostic testing menu, which currently comprises LDTs for molecular diagnostics (mpox Clade I and II and SARS-CoV-2) and pharmacogenetic testing (TR8 PGx).
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