The Yourgene Insight DPYD assay detects 19 variants to help clinicians screen for dihydropyrimidine dehydrogenase deficiency in patients receiving 5-fluorouracil.
Yourgene Health launched the Yourgene Insight DPYD assay, a genotyping test designed to identify cancer patients with dihydropyrimidine dehydrogenase (DPD) deficiency. The assay is intended to help clinicians adjust treatments for patients at risk of severe or lethal side effects from 5-fluorouracil (5-FU), a chemotherapy drug used for colorectal, head and neck, breast, pancreatic, and stomach cancers.
According to the company, more than 2 million cancer patients are treated with fluoropyrimidines like 5-FU each year. Between 10% and 20% of these patients suffer severe side effects associated with DPD deficiency.
The Insight DPYD assay expands the number of detectable genetic variants from six in the original 2019 test to 19. This update aligns with joint consensus guidelines from the Association for Molecular Pathology and the American College of Medical Genetics and Genomics. The test includes the 14 variants recommended by these organizations plus five additional variants for broader global relevance.
The assay utilizes an amplification refractory mutation system allele-specific amplification workflow. The kit includes ready-to-use reagents and provides results on the same day, which helps prevent delays in starting chemotherapy treatment.
The product is initially available for Research Use Only. Yourgene Health, a part of the Novacyt Group, plans to seek In Vitro Diagnostic Regulation and other regulatory territory approvals in the future.
“We are pleased to have launched the Yourgene Insight DPYD assay on schedule, enabling a streamlined, cost-effective pharmacogenetic workflow that supports safer, more personalised treatment decisions for cancer patients at risk of suffering a severe, and potentially life-threatening reaction to common chemotherapy,” says Lyn Rees, CEO of Novacyt, in a release. “The new kit delivers a deeper insight and greater confidence for clinical decision-making, helping reduce adverse side effects while improving patient safety.”
Photo caption: Yourgene Insight DPYD assay
Photo credit: Yourgene Health
