Novacyt Launches Yourgene Insight DPYD, a Genetic Test Prior to Chemotherapy
Novacyt announced on Tuesday the launch of the Yourgene Insight DPYD test, designed to identify cancer patients with a deficiency in dihydropyrimidine dehydrogenase (DPD) before chemotherapy treatment. The test, originally developed in 2019, has been enhanced to detect 19 genetic variants, including the 14 recommended by the updated guidelines of the Association for Molecular Pathology (AMP) and the American College of Medical Genetics and Genomics (ACMG).
Extended Variant Detection and Clinical Improvement
The test identifies patients with a DPD deficiency, an enzyme involved in the metabolism of 5-fluorouracil (5-FU), a chemotherapy drug commonly used in the treatment of colorectal, head and neck, breast, pancreatic, and stomach cancers. Between 10 and 20% of patients treated with fluoropyrimidines suffer from severe, sometimes fatal, side effects due to this deficiency. The Yourgene Insight DPYD test offers the same workflow and format as the original kit, with ready-to-use reagents, straightforward result interpretation, and a rapid turnaround time that allows for same-day results.
Regulatory Status and Market Context
The product was launched for research use only (RUO), with regulatory approvals for in vitro diagnostic medical devices (IVDR) and other regulatory territories expected in due course. Many countries have already implemented DPYD genotyping before prescribing chemotherapy treatment, following a mixed model of private payment and reimbursement.
