Applied DNA receives approval for TR8(TM) pharmacogenomic testing (PGx) 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, announced today that the New York State Department of Health (“NYSDOH”) approved the Testing Service pharmacogenomic (PGx) TR8™ PGx (“TR8”). The company is currently in discussions to offer large-scale testing to enterprise customers, healthcare networks and concierge physicians looking to add PGx testing to their testing menu.

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

“The standards set by the NYSDOH are among the most rigorous in the nation, and approval of our TR8 testing service marks an important regulatory milestone for the company. We believe New York State is a green market for PGx testing, and we are actively recruiting testing volume through partnerships with employers, health care systems and large-scale enterprises to establish market share,” said Dr. James A. Hayward, president and CEO of Applied DNA. “The launch of this testing service fulfills 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 New Yorkers PGx testing, which we believe it has great potential to help them live their healthiest lives.”

TR8™ PGx – Enterprise-grade pharmacogenomic testing

The TR8 PGx test analyzes 120 genetic targets in 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 management, oncological, psychiatric and pain. The test is administered by means of a simple swab on the cheek.

Armed with information about a patient’s genome-based response to medications, healthcare providers can make better decisions when choosing prescription medications that optimize the quality and efficiency of healthcare. Studies have shown that PGx testing can reduce institutional healthcare costs, improve population well-being and increase productivity when deployed in enterprise-scale applications such as healthcare systems, institutions and self-insured companies.^1,2,3,4the latter accounting for about 65% of all US employers in 2023⁵.

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

Footnotes:
¹ Jarvis, JP, Peter, AP, Keogh, M., Baldasare, V., Beanland, GM, Wilkerson, ZT, Kradel, S., & Shaman, JA (2022). Real-world impact of a comprehensive pharmacogenomics-enriched 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, multicenter, controlled, cluster-randomized 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 associated with a pharmacist-directed pharmacogenomic service for the Comprehensive Care Program for the Elderly. Pharmacogenomics. 2020; 21 (10): 651-661
⁴ Bradley P, Shiekh M, Mehra V, et al. Improved efficacy with pharmacogenetics-guided targeted 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 that develops 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 main business markets: (i) the enzymatic production of synthetic DNA for use in the manufacture of therapeutics with nucleic acid base and, through our recent acquisition of Spindle Biotech, Inc. (“Spindle”), the development and sale of a proprietary RNA polymerase (“RNAP”) for use in the manufacture of mRNA therapeutics; (ii) DNA and RNA detection in molecular diagnostic and genetic testing services; and (iii) DNA production and detection for industrial supply chain security services.

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Laboratory/Test Information

Applied DNA Clinical Labs, LLC (“ADCL”) is a NYSDOH CLEP, Clinical Laboratory Improvement Amendments (“CLIA”) certified clinical laboratory certified to perform high complexity testing. The TR8 test was developed and its performance characteristics determined by ADCL. The TR8 test has not been cleared or approved by the US Food and Drug Administration. The TR8 test is intended for clinical purposes.

Forward-looking statements

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 Securities 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 may differ materially from those anticipated due to historical net losses, limited financial resources, unknown future demand for its PGx testing service, unknown amount of revenues and profits that will result from our PGx testing service, FDA status unknown. continued enforcement discretion with respect to laboratory-developed tests including laboratory-developed PGx tests, and other other factors detailed from time to time in the SEC’s reports and filings of Applied DNA, including its Report 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 in available at www.sec.gov. Applied DNA does not undertake to publicly update any forward-looking statement to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unforeseeable 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
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SOURCE: Applied DNA Sciences, Inc.

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