The pharmacogenetic test detects 19 variants to identify cancer patients at risk of severe toxicity from fluoropyrimidine treatments.
Yourgene Health, part of the Novacyt Group, announced the commercial launch of its In Vitro Diagnostic Regulation (IVDR)-certified Yourgene Insight DPYD assay across regulated European markets.
The launch follows the introduction of the assay as a Research Use Only (RUO) product in May 2026 and marks the completion of the test’s transition to full compliance with European Union IVDR standards, the company reported.
Identifying Chemotherapy Toxicity Risk
The Yourgene Insight DPYD assay enables the detection of 19 clinically relevant variants in the dihydropyrimidine dehydrogenase (DPYD) gene, according to the release. These genetic markers assist clinical laboratories and clinicians in identifying patients who face an increased risk of severe toxicity associated with fluoropyrimidine-based chemotherapy.
According to the company, the assay is the first CE-marked IVDR DPYD test to incorporate all current Tier 1 and Tier 2 variants recommended by both the Association for Molecular Pathology (AMP) and the National Comprehensive Cancer Network (NCCN).
Laboratory Workflow and Implementation
The diagnostic test uses an amplification refractory mutation system (ARMS) allele-specific amplification workflow, the company stated. According to the release, the workflow incorporates ready-to-use reagents, straightforward data interpretation tools, and simplified testing steps to support routine molecular diagnostic operations and accelerate turnaround times for personalized therapy selections.
The assay was developed in collaboration with clinicians and extensively evaluated to meet the testing needs of routine clinical laboratories, according to Yourgene Health.
“The launch of the IVDR-certified Yourgene Insight DPYD assay is an important milestone for Novacyt and demonstrates our ability to translate scientific innovation into clinically relevant products that address urgent healthcare needs,” says Lyn Rees, CEO of Novacyt, in a release. “As precision medicine continues to evolve, pharmacogenomic testing is becoming increasingly important in supporting safer and more effective treatment decisions. By delivering the first IVDR-certified DPYD assay incorporating all recommended Tier 1 and Tier 2 variants, we are providing laboratories with a comprehensive solution that aligns with the latest clinical guidance. This launch further strengthens our clinical genetics portfolio and supports our strategy of building a differentiated, high-value molecular diagnostics business.”
Photo caption: Yourgene Insight DPYD
Photo credit: Yourgene Health
