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

Rhea-AI Summary

Applied DNA Sciences (NASDAQ:APDN) has submitted a validation package to the New York State Department of Health for approval of its laboratory-developed test (LDT) for detecting H5 bird flu. The company's Linea™ Avian Influenza H5 Dx assay (AIH5 Dx) is designed to detect and differentiate between pan-influenza A and H5 bird flu.

The development was initiated in January 2025 following increased concerns about H5 bird flu spread in dairy cows and poultry, along with human infections in U.S. workers. If approved, Applied DNA Clinical Labs (ADCL) will launch a testing service accepting samples from states recognizing New York's CLEP/CLIA certification.

The testing would be conducted at ADCL, an NYSDOH CLEP-permitted, CLIA-certified laboratory, adding to its existing diagnostic testing menu that includes mpox, SARS-CoV-2, and pharmacogenetic testing. The timeline for NYSDOH's review and potential approval remains uncertain.

Positive

• Development of new diagnostic test for emerging health threat
• Potential expansion of diagnostic testing services portfolio
• Leverages existing laboratory infrastructure and workflows

Negative

• Uncertain timeline for regulatory approval
• No guarantee of NYSDOH approval
• Revenue impact dependent on approval and market adoption

Insights

Healthcare Regulatory Analyst

Applied DNA's submission of a validation package for their H5 bird flu test represents a strategic positioning in the infectious disease diagnostics market amid emerging health concerns. The company is leveraging current public health dynamics - with the CDC actively recommending rapid subtyping of influenza A specimens and reporting potential underestimation of human H5 infections.

The regulatory pathway chosen (laboratory-developed test through NYSDOH) is significantly faster than pursuing FDA authorization, allowing for quicker market entry if approved. However, investors should note several key uncertainties: no timeline for regulatory review, no guarantee of approval, and no revenue projections.

From an operational perspective, Applied DNA appears well-positioned to integrate this test into existing infrastructure, citing their CLIA-certified laboratory capabilities and established diagnostic testing menu. Their reference to previous success in developing tests for emergent health threats (mpox, SARS-CoV-2) suggests institutional experience with this regulatory pathway.

The scientific rationale for developing this test appears sound, with the company citing specific research from Scripps identifying mutations that could enhance human-to-human transmission. This test could serve an important surveillance function in identifying such mutations early.

While representing potential diversification of Applied DNA's diagnostic portfolio, this development remains in the regulatory approval phase with significant execution risk before commercialization.

Biotechnology Investment Specialist

This submission represents Applied DNA's attempt to capitalize on a potential emerging diagnostic opportunity with their PCR testing platform. The company is strategically positioning its clinical laboratory subsidiary to address H5 bird flu detection needs at a time when public health concerns are rising.

Market context is important here - the diagnostic testing landscape for avian influenza currently lacks widespread commercial availability, potentially creating favorable positioning if approval is secured. However, the addressable market remains difficult to quantify as human infections are still relatively

Financial implications are speculative at this stage. The company's approach of utilizing existing assets and workflows suggests minimal incremental investment required, which is favorable for their capital efficiency. However, this submission represents just one step in a multi-stage approval and commercialization process.

For Applied DNA (market cap: $2.3M), securing this approval could represent a meaningful addition to their current diagnostic menu, which includes tests for mpox, SARS-CoV-2, and pharmacogenetic testing. Their strategy appears to focus on rapidly responding to emerging health concerns rather than competing in commoditized testing markets.

Investors should monitor both approval timelines and subsequent commercialization efforts, including reimbursement strategies and laboratory testing volume, to gauge actual revenue impact. Without these metrics, the immediate financial impact remains uncertain despite the strategic alignment with public health trends.

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:

¹ Lin, 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

² Leonard, 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.

Visit adnas.com for more information. Follow us on X and LinkedIn.

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.

View the original press release on ACCESS Newswire

FAQ

What is the purpose of Applied DNA's new H5 bird flu test (AIH5 Dx)?

The test is designed to detect and differentiate between pan-influenza A and H5 bird flu, particularly amid rising concerns of virus spread in dairy cows and human infections in U.S. workers.

When did APDN submit the H5 bird flu test validation package to NYSDOH?

Applied DNA submitted the validation package in March 2025 to the New York State Department of Health for approval as a laboratory-developed test.

What states will have access to APDN's H5 bird flu testing if approved?

The test will be available in all U.S. states that recognize New York's CLEP/CLIA certification.

What other diagnostic tests are currently offered by Applied DNA Clinical Labs?

ADCL currently offers molecular diagnostics for mpox Clade I and II, SARS-CoV-2, and pharmacogenetic testing (TR8 PGx).