Yourgene Health, part of the Novacyt Group, has commercially launched its IVDR-certified Yourgene Insight DPYD assay, expanding its molecular diagnostics portfolio for clinical laboratories across regulated European markets. The new test is designed to help identify genetic variants that can indicate whether patients face a higher risk of severe toxicity from certain chemotherapy treatments.
The launch marks the next stage in the development of the assay, which was initially introduced as a Research Use Only product in May 2026. Following the completion of its regulatory transition, the test now meets the European Union’s In Vitro Diagnostic Regulation requirements, allowing Yourgene Health to pursue broader clinical use and commercial opportunities across Europe.
The development has particular relevance to cancer chemotherapy, where patients can respond very differently to the same medicines. Fluoropyrimidine-based drugs are widely used in cancer treatment, but certain inherited variants in the DPYD gene can reduce a patient’s ability to process these medicines and increase the risk of serious toxicity. Identifying those variants before treatment can provide clinicians with information to consider when planning therapy.
Yourgene Insight DPYD Targets Clinically Relevant Genetic Variants
The Yourgene Insight DPYD assay has been developed to detect 19 clinically relevant variants in the DPYD gene. These variants are associated with changes in the body’s ability to metabolise fluoropyrimidine medicines, including chemotherapy drugs used across several cancer treatment settings.
The test is intended to provide laboratories and clinicians with genetic information that can support treatment decisions. For patients carrying relevant DPYD variants, understanding their genetic status before receiving fluoropyrimidine-based therapy can help healthcare professionals assess potential toxicity risks and consider appropriate management strategies.
The assay’s coverage is a key feature of the product. Yourgene Health says it is the first CE-marked DPYD test under the IVDR to include all current Tier 1 and Tier 2 variants recommended by both the Association for Molecular Pathology and the National Comprehensive Cancer Network.
That broader coverage could be significant for clinical laboratories looking for a single testing solution aligned with established professional guidance. As pharmacogenomic testing becomes more closely integrated into oncology, laboratories are under growing pressure to provide results that are both clinically relevant and compatible with routine workflows.
Yourgene has designed the test around an ARMS, or amplification refractory mutation system, allele-specific amplification process. The workflow uses ready-to-use reagents and accompanying tools intended to make data interpretation more straightforward for laboratory teams.
Ease of use can be an important consideration when molecular tests move from specialist research environments into routine clinical practice. A test may offer valuable genetic information, but its practical impact also depends on how efficiently laboratories can process samples and deliver results to clinicians.
The assay has also undergone extensive evaluation and was developed in collaboration with clinicians. That development process was intended to ensure that the test addresses the requirements of laboratories handling pharmacogenomic testing in everyday clinical settings.
For the cancer chemotherapy market, the growing adoption of pharmacogenomics reflects a broader effort to make treatment decisions more tailored to individual patients. Genetic testing can help identify differences in how medicines may be processed, potentially giving physicians additional information before a treatment course begins.
IVDR Certification Opens New Commercial Opportunities in Europe
The move from RUO status to full IVDR certification represents an important commercial step for Yourgene Health. Regulatory compliance is particularly significant in the European diagnostics market, where manufacturers must meet detailed requirements before certain in vitro diagnostic products can be marketed for clinical use.
The certification gives Yourgene an opportunity to expand the commercial reach of the DPYD assay across regulated European markets. It also strengthens the company’s position in clinical genetics, an area where demand is being supported by the wider adoption of precision medicine and pharmacogenomic testing.
For Novacyt, the launch adds another clinically focused product to its molecular diagnostics portfolio. The company has been working to expand beyond conventional diagnostic applications by developing and commercialising tests that address specific clinical needs.
Lyn Rees, chief executive officer of Novacyt, described the IVDR-certified launch as an important milestone for the company and highlighted the growing role of pharmacogenomic testing in treatment decisions. He also pointed to the assay’s inclusion of recommended Tier 1 and Tier 2 DPYD variants as an important differentiating feature.
The commercial timing is notable as healthcare systems increasingly look for ways to reduce avoidable treatment complications while maintaining access to effective medicines. In oncology, the ability to identify patients who may be particularly vulnerable to chemotherapy-related toxicity can be valuable for clinicians managing complex treatment decisions.
The broader market opportunity extends beyond the test itself. Greater use of pharmacogenomic testing could increase demand for laboratory services, genetic interpretation and clinical workflows capable of incorporating test results into treatment planning.
Yourgene’s DPYD assay provides a focused example of this shift. Instead of using genetic testing solely to diagnose inherited disease, the technology is being applied to help determine how a patient’s genetic profile may affect their response to a medicine.
The IVDR certification therefore gives the company both a regulatory milestone and a pathway toward wider adoption. As European laboratories continue to implement precision medicine approaches, tests that combine established clinical guidance with practical laboratory workflows could gain greater relevance.
With the commercial launch of the Yourgene Insight DPYD assay, Yourgene Health is strengthening its presence in clinical molecular diagnostics while targeting a specific challenge in cancer chemotherapy. The company’s expansion into regulated European markets also highlights the growing commercial importance of pharmacogenomics as healthcare providers seek more personalised and informed approaches to cancer treatment.
