Yourgene Health Launches Insight DPYD Assay

Enhanced pharmacogenetic workflow includes additional variants to support safer, personalised chemotherapy treatment for cancer patients

PARIS & MANCHESTER, England--(BUSINESS WIRE)--Yourgene Health (part of the Novacyt Group), an international molecular diagnostics company with a broad portfolio of integrated technologies and services, announces the launch of Yourgene^® Insight DPYD assay, an assay utilising genetic insights for safer chemotherapy treatments to align with updated testing guidelines.

Yourgene Insight DPYD is a simple-to-use genotyping test that can identify cancer patients with dihydropyrimidine dehydrogenase (DPD) deficiency, which can cause severe and sometimes lethal side effects in patients being treated with chemotherapeutic drug 5-fluorouracil (5-FU), commonly used in the treatment of colorectal, head and neck, breast, pancreatic and stomach cancers. Over two million cancer patients globally are treated with fluoropyrimidines (including 5-FU) each year*; 10–20% of these patients suffer severe, and sometimes fatal side effects associated with DPD deficiency**. Screening patients for DPYD variants allows treatments to be adjusted accordingly.

Following updated guidelines from a joint consensus of organisations such as AMP (Association for Molecular Pathology) and ACMG (American College of Medical Genetics and Genomics), the 2019 original Yourgene DPYD test has been enhanced to enable the number of variants to be detected to increase from six to 19. This includes the 14 recommended by these updated guidelines, plus five additional variants for broader coverage and enhanced global relevance to support safer, more informed chemotherapy treatment decisions, demonstrating the Company’s ability to meet clinicians’, laboratories’ and patients’ needs. The product has been launched for Research Use Only (RUO) initially with In Vitro Diagnostic Regulation (IVDR) and other regulatory territory approvals to follow in due course. Many countries have already implemented DPYD genotyping ahead of prescribing chemotherapy treatment and there is a mixed model of private pay and reimbursement.

The Yourgene Insight DPYD test has the same ARMS (amplification refractory mutation system) allele specific amplification workflow and format as the original DPYD kit, with ready-to-use reagents, simple data interpretation to identify the presence or absence of 19 variants and a fast turnaround time enabling results to be provided the same day, helping to ensure there is no delay in patients starting their chemotherapy treatment.

The Company has continued to invest in research and development to expand its product portfolio, and is now translating this into commercially launched products and tangible pipeline progress.

For further information about the Yourgene Insight DPYD Assay and the full list of variants covered, please visit: https://yourgenehealth.com/products/yourgene-insight-dpyd/.

^*D. Meulendijks et al., Cancer Treatment Reviews (2016)

^**Average: Chan et al., British Journal of Cancer (2024); Cancer Research UK https://bit.ly/2kLn1uT; Merloni et al., Cancer Drug Resist. (2019)