Expanded DPYD Genotyping Test Supports Safer Chemotherapy Dosing

Fluoropyrimidines such as 5-fluorouracil (5-FU) are chemotherapy drugs prescribed to more than two million cancer patients each year, but 10–20% of patients can experience severe, and sometimes fatal, toxicities associated with dihydropyrimidine dehydrogenase (DPD) deficiency. Pre-treatment DPYD genotyping can help guide dose adjustments across colorectal, head and neck, breast, pancreatic, and stomach cancers to reduce this risk. A newly updated test expands variant coverage and standardizes laboratory workflow, supporting safer and more informed chemotherapy decisions.

Yourgene Health (Manchester, UK), part of the Novacyt Group, has introduced the Yourgene Insight DPYD assay to align with updated testing guidance from organizations such as the Association for Molecular Pathology (AMP) and the American College of Medical Genetics and Genomics (ACMG). Building on a 2019 version, the assay increases detectable DPYD variants from six to 19. The expanded panel includes 14 variants recommended in the updated guidance plus five additional markers to provide broader coverage and global relevance.

The assay is a genotyping test designed to identify patients with DPD deficiency who are at risk of severe adverse effects when treated with 5‑fluorouracil. It uses an amplification refractory mutation system (ARMS) allele‑specific amplification workflow with ready‑to‑use reagents. Results are interpreted as presence or absence across the 19 targeted variants, with a fast turnaround that enables same‑day reporting and helps avoid delays to the start of chemotherapy.

The launch is initially for Research Use Only, with In Vitro Diagnostic Regulation and other territorial approvals to follow in due course. Many countries already conduct DPYD genotyping before prescribing fluoropyrimidines, supported through a mix of private payment and reimbursement models. By expanding variant coverage while preserving a streamlined workflow, the assay is positioned to support safer, personalized chemotherapy dosing decisions.

Ongoing research and development is expanding the company’s product portfolio and translating into commercially launched products and tangible pipeline progress. The Insight DPYD addition reflects this pharmacogenetic focus. Additional information, including the full list of covered variants, is available from the company.

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