Yourgene Health (part of the Novacyt Group), has launched the In Vitro Diagnostic Regulation (IVDR)-certified Yourgene Insight DPYD assay, expanding its clinical genetics portfolio across regulated European markets.
The launch follows the introduction of the Yourgene Insight DPYD assay as a Research Use Only (RUO) product in May and completes the assay’s regulatory transition to full compliance with the European Union’s IVDR.
The Yourgene Insight DPYD assay accurately detects 19 clinically relevant variants in the dihydropyrimidine dehydrogenase (DPYD) gene, thus helping identify patients at increased risk of severe toxicity from fluoropyrimidine-based chemotherapy. The assay provides laboratories and clinicians with an important tool to support informed treatment decisions and improve patient management, according to the companuy.
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), providing laboratories with a comprehensive solution aligned with the latest clinical guidance. The ARMS (amplification refractory mutation system) allele-specific amplification workflow includes ready-to-use reagents and simple data interpretation tools to expedite personalized treatment decisions. It has been developed in close collaboration with clinicians and has undergone extensive evaluation to ensure it meets the testing needs of routine clinical laboratories.
The IVDR certification broadens the product’s commercial opportunity, particularly across highly regulated European markets, and represents continued growth of the company’s molecular diagnostics portfolio.
“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,” Novacyt CEO Lyn Rees said. “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 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.”
Yourgene Health, part of the Novacyt Group, offers genomic technologies and services, primarily focused on molecular diagnostics for reproductive health and precision medicine. Yourgene also has a portfolio of instrumentation, powered by Ranger Technology, enabling automated sample preparation and target DNA enrichment. The company provides non-invasive prenatal testing (NIPT) solutions, including a complete NGS workflow that provides laboratories with flexible, scalable testing and a broad clinical menu, tailored to their needs. In addition, the firm provides a clinical NIPT sample service through its Manchester Genomic Service Laboratory for healthcare professionals. The IONA test pioneered the NIPT screening landscape in 2015 as the first in-vitro diagnostic NIPT assay available on the market.
Supporting the wider reproductive lifecycle, Yourgene Health offers PCR-based clinical screening assays, including tests for cystic fibrosis, aneuploidy analysis, pregnancy loss, male factor infertility, and thrombosis risk. As part of its expanding Precision Medicine portfolio, the company’s DPYD genotyping PCR assay supports safer chemotherapy regimens by identifying patients at risk of severe fluoropyrimidine toxicity. Early DPD deficiency detection before starting 5-FU treatment enables clinicians to adjust chemotherapy dosing and avoid serious, potentially life-threatening adverse reactions.
Powered by Ranger Technology, Yourgene Health’s automated DNA size selection instruments delivers high-precision fragment selection and dynamic target enrichment across a wide range of clinical and research sequencing applications. Designed to support laboratories from low- to high-throughput workflows, Ranger instruments provide a solution for applications including NIPT, gene synthesis, CRISPR gene editing, and long-read sequencing. Developed in close collaboration with PacBio, the LightBench Discover is fully compatible with the PacBio Revio and Vega platforms, making it ideally suited for enhancing long-read sequencing workflows. LightBench Discover is an automated three-in-one electrophoresis system combining DNA size selection, fragment length analytics, and quantification in a single benchtop solution, thereby removing the need for multiple instruments and simplifying laboratory workflows.