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

March 26, 2025 at 09:00 AM EDT

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. 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).

"This past December, scientists at Scripps Research identified a mutation in H5 bird flu that could turn the virus from one that is currently not well-equipped to infect people into one that is much more capable of doing so.¹ Last month, the Centers for Disease Control and Prevention reported that human H5 bird flu infections are potentially underestimated in the U.S.² Against this backdrop, our development of AIH5 Dx leverages our demonstrated ability to rapidly develop and gain regulatory approval for LDTs targeting emergent health crises," stated Dr. James A. Hayward, CEO of Applied DNA. "Subject to NYSDOH approval, ADCL stands ready to empower physician and patient access to testing using our existing assets and workflows."

Citations:

¹Lin, T., Zhu, X., Wang, S., Zhang, D., McBride, R., Yu, W., Babarinde, S., Paulson, J. C., & Wilson, I. A. (2024). A single mutation in bovine influenza H5N1 hemagglutinin switches specificity to human receptors. Science, 386(6726), 1128-1134. https://doi.org/10.1126/science.adt0180

²Leonard, J., Harker, E. J., Szablewski, C. M., Margrey, S. F., Gingrich, K. F., Crossley, K., Fletcher, E., McCreavy, C. J., Weis-Torres, S., Wang, D., Noble, E. K., Levine, M. Z., Pagano, H. P., Holiday, C., Liu, F., Jefferson, S., Li, Z., Gross, F. L., Reed, C., . . . Olson, S. M. (2025). Notes from the Field: Seroprevalence of Highly Pathogenic Avian Influenza A(H5) Virus Infections Among Bovine Veterinary Practitioners - United States, September 2024. MMWR Morbidity and Mortality Weekly Report, 74(4), 50-52. https://doi.org/10.15585/mmwr.mm7404a2

Laboratory/Test Information

Applied DNA Clinical Labs, LLC ("ADCL") is a NYSDOH CLEP-permitted, Clinical Laboratory Improvement Amendments ("CLIA")-certified clinical laboratory, certified to perform high-complexity testing. The Linea AIH5 Dx assay was developed, and its performance characteristics were determined by ADCL. If approved, the Linea™ AIH5 Dx assay is intended for clinical purposes.

About Applied DNA Sciences

Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid ("DNA"). Using the polymerase chain reaction ("PCR") to enable both the production and detection of DNA, we operate in two business markets: (i) the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and the development and sale of a proprietary RNA polymerase ("RNAP") for use in the production of mRNA therapeutics; and (ii) the detection of DNA and RNA in molecular diagnostics and genetic testing services.

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Forward-Looking Statements

The statements made by Applied DNA in this press release may be "forward-looking" in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA's future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Further, the uncertainties inherent in research and development, future data and analysis, including whether Linea™ AIH5 Dx will, if ever, receive approval from NYSDOH for the detection of H5 bird flu in clinical samples, and whether, even if it is approved, the Company will ever realize revenues from the test. In addition, actual results could differ materially from those projected due to the Company's history of net losses, the unknown future course of the H5 bird flu outbreak, the unknown demand, revenue and profits, if any, that will result from H5 bird flu testing, limited financial resources, and various other factors detailed from time to time in Applied DNA's SEC reports and filings, including its Annual Report on Form 10-K filed on December 17, 2024, its Quarterly Report on Form 10-Q filed on February 13, 2025, and other reports it files with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

Applied DNA Sciences Contact:

Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com

Web: adnas.com

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SOURCE: Applied DNA Sciences, Inc.

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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

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