Partnership Will Aid Physicians in Precision Prescribing Decisions Based on Applied DNA's TR8 Pharmacogenomic (PGx) Test

STONY BROOK, NY / ACCESSWIRE / June 18, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a global leader in PCR-based DNA technologies, today announced that its molecular diagnostics subsidiary, Applied DNA Clinical Labs, LLC (ADCL), will utilize the GenXys Health Care Systems (GenXys) suite of clinical decision support software for interpretation and reporting of ADCL's New York State Department of Health-approved TR8 pharmacogenomic (TR8 PGx) test. The partnership is designed to improve patient outcomes and reduce healthcare costs through a data-driven approach that relates an individual's genetic factors to potential responses to prescription drugs.

Dr. James Hayward, president and CEO of Applied DNA, stated, "We at ADCL believe that PGx-enabled precision prescribing provides numerous benefits to patients, payors, and healthcare as a whole - all empowered by a simple buccal swab. A single test provides a lifetime of guidance (video) and can provide a significant return on investment, especially for large healthcare networks. To realize these benefits, healthcare providers must have easy-to-understand information about potential drug-gene interactions identified by PGx testing. We believe that GenXys offers best-in-class PGx clinical integration services, and we are excited to partner with GenXys as our go-to-market partner for our TR8 PGx test."

Applied DNA's TR8 PGx assay simultaneously interrogates 120 genetic variants across more than 30 genes that have been shown to affect the rate with which the body absorbs, activates, distributes, and metabolizes drugs, which can, in turn, impact the efficacy and safety of medications. The genetic variations targeted by TR8 PGx are relevant to a broad range of medicines, including cardiac, pain management, cancer, and psychiatric drugs.

The genetic variants identified by the TR8 PGx test will be processed by the GenXys clinical decision support software to identify potentially actionable drug-gene interactions that can help guide precision prescribing decisions by a healthcare provider. Numerous studies have shown that PGx-guided precision prescribing can improve therapeutic efficacy and patient compliance and diminish adverse reactions and rehospitalizations.

Applied DNA's TR8 PGx test and testing service was recently approved by the New York State Department of Health (NYSDOH) for commercial use. The test will be deployed in ADCL's CLEP/CLIA-certified laboratory.

Learn more about TR8 PGx:

About GenXys Health Care Systems

GenXys, with a presence across North America, provides the world's most comprehensive precision prescribing solutions with embedded pharmacogenetics to solve one of healthcare's biggest challenges: inappropriate ("trial-and-error") prescribing. GenXys' clinical decision support software suite is in use by major insurance providers, health systems, pharmacies and their pharmacogenetic labs across North America. Ongoing global clinical studies are paving the way into geographical markets to enable GenXys to realize its vision of making every prescription better with its software to increase patient safety, improve population health, and reduce healthcare costs. genxys.com

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 and is available via prescription only.

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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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 associated clinical decision support systems, 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.

Contacts:

Applied DNA Sciences
Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
Program contact: pgx@adnas.com
Web:
X: @APDN

SOURCE: Applied DNA Sciences, Inc.