Novacyt Secures IVDR Certification for DPYD Genetic Testing Assay

Novacyt has secured IVDR certification for its Yourgene Insight DPYD assay, authorizing the commercial distribution of the 19-variant genetic test across European markets. The certification allows the diagnostic tool to move from a research-only application to a clinically validated product used to screen for severe chemotherapy toxicity.

"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," said Lyn Rees, Chief Executive Officer of Novacyt.

Clinical Utility of the DPYD Assay

The Yourgene Insight DPYD assay detects 19 clinically relevant variants within the DPYD gene. These genetic markers help clinicians identify patients who face an increased risk of severe, potentially life-threatening toxicity when treated with fluoropyrimidine-based chemotherapy, which is a common treatment for various cancers.

By identifying these variants before treatment begins, healthcare providers can adjust dosages or select alternative therapies to reduce the risk of adverse reactions. The assay's certification under the In Vitro Diagnostic Regulation (IVDR) provides the regulatory assurance required for its use in clinical diagnostic settings across the European Union and other jurisdictions that adhere to the framework.

Transition From Research to Clinical Use

Novacyt initially introduced the DPYD assay as a Research Use Only (RUO) product in May 2026. While RUO products are intended for scientific investigation, they lack the regulatory validation required for use in patient diagnostic decision-making. The transition to IVDR certification confirms that the assay meets the performance, safety, and quality standards mandated by updated European regulations.

This development is part of Novacyt's strategy to expand its portfolio of molecular diagnostics. Achieving this certification validates the company's internal development process for translating laboratory-developed tests into standardized, commercially available diagnostic kits.