Yourgene Health launches insight DPYD assay
Enhanced pharmacogenetic workflow includes additional variants to support safer, personalised chemotherapy treatment for cancer patients
19 May 2026
Yourgene Health (part of the Novacyt Group), an international molecular diagnostics company, has launched the Yourgene Insight® DPYD assay, a pharmacogenetic genotyping test designed to identify cancer patients with dihydropyrimidine dehydrogenase (DPD) deficiency and support safer, personalised chemotherapy treatment decisions in line with updated international testing guidelines.
Supporting personalised chemotherapy for cancer patients
The Yourgene Insight DPYD assay is a simple-to-use genotyping test that identifies cancer patients with DPD deficiency, a genetic condition that can cause severe and sometimes lethal side effects in patients treated with the chemotherapeutic drug 5-fluorouracil (5-FU). Fluoropyrimidines, including 5-FU, are commonly used in the treatment of colorectal, head and neck, breast, pancreatic and stomach cancers.
More than two million cancer patients worldwide receive fluoropyrimidine-based chemotherapy each year1. An estimated 10–20% of these patients experience severe, and sometimes fatal, side effects associated with DPD deficiency2,3,4. By screening patients for DPYD variants before treatment, clinicians can adjust chemotherapy regimens to reduce the risk of toxicity and improve patient safety.
Expanded DPYD variant coverage aligned with updated guidelines
Following updated guidelines from a joint consensus of organisations including the Association for Molecular Pathology (AMP) and the American College of Medical Genetics and Genomics (ACMG), Yourgene Health has enhanced its original 2019 DPYD test. The new Yourgene Insight DPYD assay increases the number of detectable variants from six to 19.
This expanded panel includes the 14 variants recommended by the updated guidelines, plus five additional variants to provide broader coverage and enhanced global relevance. The extended variant coverage is designed to support safer, more informed chemotherapy treatment decisions and demonstrates the company’s ability to meet the evolving needs of clinicians, laboratories and patients.
The Yourgene Insight DPYD assay has been launched for Research Use Only (RUO) initially. In Vitro Diagnostic Regulation (IVDR) and other regulatory approvals in additional territories are expected to follow. Many countries have already implemented DPYD genotyping prior to prescribing chemotherapy, supported by a mixed model of private pay and reimbursement.
Streamlined ARMS-based workflow for rapid results
The Yourgene Insight DPYD test uses the same ARMS (amplification refractory mutation system) allele-specific amplification workflow and format as the original DPYD kit. The assay features ready-to-use reagents, straightforward data interpretation to determine the presence or absence of 19 variants, and a fast turnaround time that enables same-day results.
This streamlined workflow is designed to integrate efficiently into existing laboratory processes, helping ensure there is no delay in patients starting their chemotherapy treatment while still enabling personalised dose adjustments based on genetic risk.
Ongoing investment in pharmacogenetics and product innovation
Yourgene Health continues to invest in research and development to expand its molecular diagnostics and pharmacogenetic product portfolio. The launch of the Yourgene Insight DPYD assay reflects the company’s strategy to translate scientific innovation into commercially available products and tangible pipeline progress.
By focusing on clinically relevant genetic markers such as DPYD variants, Yourgene Health aims to support precision oncology, reduce adverse drug reactions and improve outcomes for cancer patients worldwide.
Leadership perspective on the new DPYD assay
Lyn Rees, Chief Executive Officer of Novacyt, commented: “We are pleased to have launched the Yourgene Insight DPYD assay on schedule, enabling a streamlined, cost-effective pharmacogenetic workflow that supports safer, more personalised treatment decisions for cancer patients at risk of suffering a severe, and potentially life-threatening reaction to common chemotherapy. By listening to customer feedback and working with key opinion leaders, we have ensured additional variants have been included in the test enhancing our global coverage for the product, strengthening our market position. The new kit delivers a deeper insight and greater confidence for clinical decision-making, helping reduce adverse side effects while improving patient safety.”
1. Meulendijks D, et al. Cancer Treat Rev. 2016.
2. Chan X, et al. Br J Cancer. 2024
3. Cancer Research UK. Fluorouracil (5FU) [Internet]. Available from: https://www.cancerresearchuk.org. Accessed May 19, 2026.
4. Merloni F, et al. Cancer Drug Resist. 2019.
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How does the Yourgene Insight® DPYD assay support safer, personalized chemotherapy treatment for cancer patients?
The Yourgene Insight® DPYD assay is a pharmacogenetic genotyping test developed by Yourgene Health (part of the Novacyt Group) to identify cancer patients with dihydropyrimidine dehydrogenase (DPD) deficiency. DPD deficiency is a genetic condition that can cause severe and sometimes lethal side effects in patients treated with fluoropyrimidine-based chemotherapy, including 5-fluorouracil (5-FU). By screening for DPYD variants before treatment, clinicians can identify patients at increased risk of toxicity and adjust fluoropyrimidine chemotherapy regimens accordingly. This supports safer, more personalized chemotherapy decisions for patients with colorectal, head and neck, breast, pancreatic and stomach cancers.
What DPYD variant coverage does the new Yourgene Insight DPYD assay provide in line with updated AMP and ACMG guidelines?
Following updated guidelines from a joint consensus of organizations including the Association for Molecular Pathology (AMP) and the American College of Medical Genetics and Genomics (ACMG), Yourgene Health has expanded its original 2019 DPYD test. The new Yourgene Insight DPYD assay increases the number of detectable DPYD variants from six to 19. This expanded panel includes the 14 variants recommended by the updated international guidelines, plus five additional variants to provide broader coverage and enhanced global relevance. The extended variant coverage is designed to support safer, more informed chemotherapy treatment decisions and to meet the evolving needs of clinicians, laboratories and patients worldwide.
What workflow and regulatory status characterize the Yourgene Insight DPYD assay for clinical laboratories using fluoropyrimidine-based chemotherapy testing?
The Yourgene Insight DPYD assay uses an ARMS (amplification refractory mutation system) allele-specific amplification workflow, maintaining the same format as the original DPYD kit. It features ready-to-use reagents, straightforward data interpretation to determine the presence or absence of 19 DPYD variants, and a fast turnaround time that enables same-day results. This streamlined workflow is designed to integrate efficiently into existing molecular diagnostics laboratory processes so that chemotherapy start times are not delayed while still allowing personalized dose adjustments based on genetic risk. The assay has been launched initially for Research Use Only (RUO), with In Vitro Diagnostic Regulation (IVDR) and other regulatory approvals in additional territories expected to follow, supporting broader implementation of DPYD genotyping prior to prescribing fluoropyrimidine-based chemotherapy.