Applied DNA Receives Approval for TR8(TM) Pharmacogenomic (PGx) Testing Service from New York State Department of Health

STONY BROOK, NY / ACCESSWIRE / June 13, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (“Applied DNA” or the “Company”), a leader in PCR-based DNA technologies, today announced that the New York State Department of Health (“NYSDOH”) approved the Company’s TR8™ PGx (“TR8”) pharmacogenomic (PGx) testing service. The Company is currently in discussions to provide large-scale testing to enterprise customers, healthcare networks, and concierge physicians seeking to add PGx testing to their test menu.

Applied DNA’s clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), is launching its PGx testing service to help guide healthcare providers to administer a wide range of medications relevant to cardiovascular, oncology, psychiatric, infectious disease, and pain management treatments based on a patient’s unique genetics. The service is available by prescription only and will initially target the patient population of New York State.

“The standards set by NYSDOH are one of the most rigorous in the country, and the approval of our TR8 testing service marks a significant regulatory milestone for the Company. We believe New York State is a greenfield market for PGx testing, and we are actively recruiting testing volume through partnerships with employers, healthcare systems, and large-scale enterprises to establish market share,” stated Dr. James A. Hayward, president and CEO of Applied DNA. “Launching this testing service delivers on our commitment to advance personalized medicine through cost-effective and scalable genetic testing for improved patient outcomes and reduced healthcare costs. We are pleased to bring to New Yorkers PGx testing, which we believe holds the enormous potential to help them live their healthiest lives.”

TR8™ PGx – Enterprise-scale Pharmacogenomic Testing

The TR8 PGx test analyzes 120 genetic targets across more than 30 genes to inform a healthcare provider how a patient may respond to a wide range of medications used to treat a variety of conditions, such as cardiovascular, oncology, psychiatric, and pain management. The test is administered via a simple cheek swab.

Equipped with information about a patient’s genome-based response to medications, healthcare providers can make better decisions when selecting prescription medications that optimize healthcare quality and efficacy. Studies have shown that PGx testing can lower institutional healthcare costs, improve population wellness, and increase productivity when deployed in enterprise-scale applications, such as healthcare systems, institutions, and self-insured enterprises^1,2,3,4, the latter accounting for approximately 65% of all U.S. employers in 2023⁵.

To learn more about TR8 PGx: https://adnas.com/pgx/

Footnotes:
¹ Jarvis, J. P., Peter, A. P., Keogh, M., Baldasare, V., Beanland, G. M., Wilkerson, Z. T., Kradel, S., & Shaman, J. A. (2022). Real-world impact of a pharmacogenomics-enriched comprehensive medication management program. Journal of Personalized Medicine, 12(3), 421. https://doi.org/10.3390/jpm12030421
² Jesse J Swen, Cathelijne H van der Wouden, et al., A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study, The Lancet, Volume 401, Issue 10374, 2023, pages 247-356. https://doi.org/10.1016/S0140-6736(22)01841-4. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01841-4/fulltext
³ Bain KT, Knowlton CH, Matos A. Cost avoidance related to a pharmacist-led pharmacogenomics service for the Program of All-inclusive Care for the Elderly. Pharmacogenomics. 2020;21(10):651-661
⁴ Bradley P, Shiekh M, Mehra V, et al. Improved efficacy with targeted pharmacogenetic-guided treatment of patients with depression and anxiety: A randomized clinical trial demonstrating clinical utility. J Psychiatr Res. 2018;96:100-107. doi:10.1016/j.jpsychires.2017.09.024
⁵ https://www.statista.com/statistics/985324/self-funded-health-insurance-covered-workers/

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 three primary business markets: (i) the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and, through our recent acquisition of Spindle Biotech, Inc. (“Spindle”), the development and sale of a proprietary RNA polymerase (“RNAP”) for use in the production of mRNA therapeutics; (ii) the detection of DNA and RNA in molecular diagnostics and genetic testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services.

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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 TR8 test was developed, and its performance characteristics were determined by ADCL. The TR8 test has not been cleared or approved by the U.S. Food and Drug Administration. The TR8 test is intended for clinical purposes.

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. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, unknown future demand for its PGx testing service, the unknown amount of revenues and profits that will result from our PGx testing service, the unknown status of FDA’s continued enforcement discretion with respect to laboratory developed tests including laboratory developed PGx tests, 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, as amended, filed on December 7, 2023 and Quarterly Report on Form 10-Q filed on February 8, 2024, and May 10, 2024, 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.

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

Program contact: pgx@adnas.com
Web: www.adnas.com
Twitter: @APDN

SOURCE: Applied DNA Sciences, Inc.

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