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Applied DNA Submits Validation Package to New York State Department of Health for H5 Bird Flu/Pan-Influenza A Laboratory-Developed Test

1. APDN's clinical lab submitted an LDT approval request for H5 bird flu test. 2. The AIH5 Dx assay aims to improve detection of H5N1 avian influenza.

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Why Bullish?

The approval of AIH5 Dx could enhance APDN's market position and revenue. Historical data shows diagnostics' market growth during health crises boosts stock value.

How important is it?

The submission for an LDT involves significant potential for revenue and competitiveness in healthcare diagnostics. The urgency and public health relevance of influenza diagnostics enhance its importance.

Why Short Term?

Regulatory approvals typically lead to stock price increases shortly after announcement. Positive market response may occur if NYSDOH approval is granted swiftly.

Related Companies

STONY BROOK, NY / ACCESS Newswire / March 26, 2025 / 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.

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