Yourgene Health launches IVDR-certified DPYD chemotherapy toxicity assay

Yourgene Health, a subsidiary of the Novacyt Group, has launched its Yourgene Insight DPYD assay across regulated European markets. The test has achieved In Vitro Diagnostic Regulation (IVDR) certification, marking its transition from a Research Use Only (RUO) product to a fully compliant clinical diagnostic tool.

The assay is designed to detect 19 clinically relevant variants in the dihydropyrimidine dehydrogenase (DPYD) gene. This allows clinicians to identify cancer patients at a higher risk of experiencing severe toxicity from fluoropyrimidine-based chemotherapy treatments.

According to the company, this is the first CE-marked IVDR DPYD test to include all current Tier 1 and Tier 2 variants recommended by the Association for Molecular Pathology (AMP) and the National Comprehensive Cancer Network (NCCN). The testing process utilizes an amplification refractory mutation system (ARMS) workflow, which includes ready-to-use reagents and data interpretation tools intended to streamline laboratory operations and support personalized therapy decisions.