#USA #Burlington #Labcorp #Chemotherapy #DPYD Testing

Labcorp Expands DPYD Testing for Safer Cancer Treatments

Labcorp, an innovative leader in laboratory services, has announced the launch of an expanded DPYD Genotyping test. This initiative is designed to improve the treatment experience for cancer patients by identifying those potentially at risk for severe or harmful side effects from fluoropyrimidine chemotherapy, including widely used drugs like 5-fluorouracil (5-FU) and capecitabine.

The Need for Advanced Testing

Chemotherapy, although essential in treating various cancers such as colorectal, pancreatic, gastric, breast, and head and neck cancers, can lead to severe toxicity and even fatalities due to unexpected patient reactions. Research indicates that around 9% of patients have a genetic variant in the DPYD gene, which disrupts their ability to metabolize these critical medications. This metabolic issue can exacerbate the risk of life-threatening side effects, contributing to approximately 1,300 deaths in the U.S. each year linked to 5-FU toxicity alone.

The DPYD gene serves a pivotal role in encoding the enzyme dihydropyrimidine dehydrogenase (DPD), essential for metabolizing roughly 80% of 5-FU. Patients manifesting reduced or absent enzyme activity are notably at risk of experiencing severe symptoms such as diarrhea, neutropenia, and neurotoxicity when administered 5-FU or capecitabine.

Regulatory Recommendations

In light of these findings, the U.S. Food and Drug Administration (FDA) has updated product labeling for 5-FU and capecitabine to include a boxed warning about the potential for severe adverse reactions or death among patients with complete DPD deficiency. As part of their updated guidelines, the FDA advocates for DPYD variant testing prior to initiating treatment with these drugs—except in cases where immediate intervention is crucial—while advising against the use of these agents in certain at-risk patient categories.

Aligned with these recommendations, the National Comprehensive Cancer Network (NCCN) has updated its guidelines to include references to the FDA's boxed warnings and the necessity for DPYD genetic testing. Additionally, the Clinical Pharmacogenomics Implementation Consortium (CPIC) endorses tailored treatment recommendations based on a patient's DPYD metabolizer status established through testing.

Enhancing Pharmacogenomics and Personalized Care

Labcorp is leveraging its long-standing experience in pharmacogenomic testing, having offered DPYD testing since 2006. This new expansion supports its comprehensive oncology offerings, which are designed to provide healthcare professionals with genetic insights that facilitate personalized therapy plans, minimize preventable adverse effects, and foster improved patient outcomes.

Marcia Eisenberg, Ph.D., the Chief Scientific Officer at Labcorp, stated, "Advances in pharmacogenomics are reshaping cancer care. Our expanded DPYD test identifies patients at risk for severe toxicity before treatment begins, supporting safer, more personalized care." This further solidifies Labcorp's commitment to enhancing patient-centered care via tailored medical solutions.

Availability of the Test

Healthcare professionals can request the DPYD Genotyping test through Labcorp's services. For more detailed information on this test and its implications, visit Labcorp’s DPYD Genotyping Test Page.

In conclusion, Labcorp's expanded DPYD testing represents a significant milestone in oncology, promising to not only identify patients at risk earlier in their treatment journey but also to align cancer treatment with their unique genetic profiles—ushering in an era of safer and more effective chemotherapy regimens for those battling cancer.