Yourgene Health expands DPYD genotyping assay to 19 variants for safer chemotherapy prescribing
Yourgene Health (part of the Novacyt Group) has launched the Yourgene® Insight DPYD assay, an enhanced pharmacogenetic test designed to identify cancer patients at risk of severe toxicity from fluoropyrimidine-based chemotherapy.
Addressing a significant clinical risk
Dihydropyrimidine dehydrogenase (DPD) deficiency can cause severe, and sometimes fatal, adverse reactions in patients receiving 5-fluorouracil (5-FU), a chemotherapy agent widely used in the treatment of colorectal, head and neck, breast, pancreatic and stomach cancers. More than two million cancer patients globally receive fluoropyrimidines each year, and 10-20% of these patients experience severe or fatal side effects associated with DPD deficiency. Pre-treatment DPYD genotyping allows clinicians to adjust dosing or select alternative regimens accordingly.
Expanded variant coverage
The new assay represents a significant update to the company’s original 2019 DPYD test, increasing detected variants from six to 19. The panel includes the 14 variants recommended under updated joint consensus guidelines from the Association for Molecular Pathology (AMP) and the American College of Medical Genetics and Genomics (ACMG), with five additional variants incorporated to broaden global coverage.
Variants are categorised across three tiers: Tier 1 (including c.1905+1G>A, c.1679T>G, and c.2279C>T, amongst others), Tier 2, and Other DPYD Variants – providing clinical laboratories with a structured framework for result interpretation.
Workflow and format
The Insight DPYD assay retains the ARMS (amplification refractory mutation system) allele-specific amplification workflow of its predecessor, with ready-to-use reagents and same-day turnaround. Simple data interpretation identifies the presence or absence of all 19 variants, supporting timely treatment decisions without delaying initiation of chemotherapy.
Regulatory status and market
The product has been launched for Research Use Only (RUO), with In Vitro Diagnostic Regulation (IVDR) and other regulatory territory approvals to follow. Many countries have already implemented DPYD genotyping ahead of chemotherapy prescribing, with a mixed model of private pay and reimbursement in place across different markets.
Lyn Rees, Chief Executive Officer of Novacyt, commented: “The new kit delivers a deeper insight and greater confidence for clinical decision-making, helping reduce adverse side effects while improving patient safety.”
For more information, visit: https://yourgenehealth.com/products/yourgene-insight-dpyd
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Lyn Rees, CEO, Novacyt
