The updated test includes additional DPYD variants recommended by the Association for Molecular Pathology to help identify patients who may be at risk for severe chemotherapy side effects.
Labcorp announced the availability of an expanded DPYD Genotyping test to help identify cancer patients who may be at increased risk for severe or life-threatening side effects from fluoropyrimidine chemotherapy. The expansion includes genotype testing for all Tier 1 and Tier 2 variants recommended by the Association for Molecular Pathology.
The DPYD gene encodes the DPD enzyme, which is responsible for metabolizing more than 80% of 5-fluorouracil (5-FU). Patients with reduced or absent DPD activity can experience serious side effects, including diarrhea, neutropenia, and neurotoxicity, when exposed to 5-FU or capecitabine.
Fluoropyrimidines are chemotherapy agents used to treat various cancers, including colorectal, pancreatic, breast, and head and neck. Approximately 9% of patients carry a DPYD variant that impairs their ability to break down these drugs, contributing to an estimated 1,300 deaths in the US each year from 5-FU toxicity.
“Advances in pharmacogenomics are reshaping cancer care,” says Marcia Eisenberg, PhD, chief scientific officer at Labcorp, in a release. “Our expanded DPYD test identifies patients at risk for severe toxicity before treatment begins, supporting safer, more personalized care. This expansion also strengthens Labcorp’s pharmacogenomics and oncology portfolio, complementing the company’s hereditary cancer testing, screening, diagnostic, and precision oncology offerings to support more personalized cancer care across the patient journey.”
The Food and Drug Administration (FDA) recently updated product labeling for 5-FU and capecitabine to include a Boxed Warning regarding the risk of severe adverse reactions or death in patients with complete DPD deficiency. The FDA advises testing for DPYD variants before starting treatment unless immediate intervention is required. It also recommends avoiding these drugs in patients with specific variants associated with complete deficiency.
Recent updates to National Comprehensive Cancer Network guidelines for colon cancer and other indications reference these Boxed Warnings and the recommendation for DPYD testing. Furthermore, Clinical Pharmacogenomics Implementation Consortium guidelines suggest adjusting or avoiding treatment based on a patient’s metabolizer status as determined by genetic testing.
Labcorp has offered DPYD testing since 2006 and provides pharmacogenomic testing across several specialty areas, including oncology, cardiology, and neurology. The expanded test is now available to clinicians through the company.
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