Applied DNA Positions TR8 PGx Testing Service as Pre-Emptive Testing for Safety of Fluoropyrimidine-Based Cancer Therapeutics Following Publication of Food and Drug Administration Safety Announcement

April 01, 2025 at 09:45 AM EDT

- Company Revamps Pharmacogenomics Go-To-Market Strategy, Targets Validated PGx Assay Towards Specific Use Cases -

STONY BROOK, NY / ACCESS Newswire / April 1, 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), its wholly-owned clinical laboratory subsidiary, is repositioning its TR8™ PGx pharmacogenomics testing service to offer tailored subpanels for indication-specific use cases in addition to full panel testing. The first subpanel under ADCL's new go-to-market strategy is for the pre-emptive testing of patients with genetic variants of the DPYD gene that correlate to potentially reduced or absent DPD enzyme activity necessary to metabolize fluoropyrimidines, specifically capecitabine (branded Xeloda) and fluorouracil (5-FU), two chemotherapy drugs that are widely used as part of the standard of care treatment for patients with certain cancers. The decision by ADCL follows a recent safety announcement by the Food and Drug Administration (FDA) in which the agency highlighted that patients with certain DPYD genetic variants are potentially poor or intermediate metabolizers of these two medications due to DPD enzyme deficiencies and risk drug overexposure and the potential to experience severe, and at times fatal, toxicities when taking them. ADCL's TR8 PGx test, a 120-target pharmacogenomics panel approved by the New York State Department of Health as a laboratory-developed test comprising more than 33 drug metabolism-related genes, can identify individuals with DPYD genotypes that result in potentially reduced or absent DPD enzyme activity.

Capecitabine and 5-FU are used for the treatment of colorectal, esophageal, stomach, pancreatic, breast, and cervical cancers. Approximately 924,000 prescriptions were written for fluorouracil and capecitabine in 2022, according to the most recent drug usage data available.¹Approximately 1 in 1,000 patients carry two copies of a variant in the DPYD gene, resulting in the absence of the DPD enzyme. Between 3 percent and 8 percent of the general population has one copy of a variant associated with lower levels of the DPD enzyme, showing up more frequently in African Americans.²These genotypes are at higher risk of adverse side effects from fluorouracil and capecitabine.

"The FDA's safety announcement underscores the value of genetic testing to guide treatment decisions and improve patient outcomes, and highlights the breadth of our TR8 PGx test and its potential to influence clinical decision-making across multiple therapeutic areas. To this end, we plan to introduce additional TR8 PGx subpanels that target indication-specific use cases where genetic testing has a high correlation with drug efficacy and safety, such as in oncology, cardiology, and psychiatry. We believe this revised go-to-market strategy can lower the barrier to adoption of our PGx testing services and provides enhanced utility to institutions, clinicians, and their patients," stated Dr. James A. Hayward, CEO of Applied DNA.

About TR8™ PGx - Pharmacogenomic Testing

The TR8 PGx test analyzes 120 genetic targets across more than 33 genes to inform healthcare providers about how a patient may respond to a wide range of drug therapies used to treat a variety of conditions, such as cardiovascular, oncology, psychiatric, and pain management. Equipped with information about a patient's genome-based response to medications, healthcare providers can make more informed decisions when selecting prescription medications, thereby optimizing healthcare quality and efficacy.

The test is administered via a simple cheek swab. The TR8 PGx testing service offered by ADCL was approved as a laboratory-developed test by the New York State Department of Health (NYSDOH) in June 2024.

Learn more about TR8 PGx here.

Citations:

¹ Bcps, S. P. K. P. (n.d.). Fluorouracil - Drug usage Statistics, ClinCalc DrugStats Database. https://clincalc.com/DrugStats/Drugs/Fluorouracil

²"Mass General Brigham Becomes Latest US Health System to Adopt Pretreatment DPYD Testing." Precision Medicine Online, January 16, 2025. https://www.precisionmedicineonline.com/precision-oncology/mass-general-brigham-becomes-latest-us-health-system-adopt-pretreatment-dpyd

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. The Company operates 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. Actual results could differ materially from those projected due to the Company's history of net losses, limited financial resources, unknown future demand for its TR8^TM PGx testing service, the unknown amount of revenues and profits that will result from its TR8 PGx testing service, the unknown status of FDA's continued enforcement discretion with respect to laboratory developed tests including laboratory developed PGx tests, as well as 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

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Applied DNA Positions TR8 PGx Testing Service as Pre-Emptive Testing for Safety of Fluoropyrimidine-Based Cancer Therapeutics Following Publication of Food and Drug Administration Safety Announcement

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