Applied DNA positions TR8 PGx testing as pre-emptive for therapeutic safety

Applied DNA Sciences (APDN) announced that Applied DNA Clinical Labs 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 and fluorouracil, 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 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.