On April 1, 2025 Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the "Company"), a leader in PCR-based DNA technologies, reported 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 (Press release, Applied DNA Sciences, APR 1, 2025, View Source [SID1234651711]). 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.
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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.1 Approximately 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.2 These 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.