Yourgene Health announces IVDR accreditation and commercial launch of Insight DPYD assay

The assay detects 19 clinically relevant DPYD gene variants linked to chemotherapy toxicity.

Yourgene Health (part of the Novacyt Group) announced the commercial launch of the Yourgene Insight DPYD assay, following its In Vitro Diagnostic Regulation (IVDR) accreditation.

The Yourgene Insight DPYD assay enables the accurate detection of 19 clinically relevant variants in the dihydropyrimidine dehydrogenase (DPYD) gene, supporting the identification of patients at increased risk of severe toxicity from fluoropyrimidine-based chemotherapy.

The assay is the first CE marked in accordance with 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). 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.

Visit Yourgene Health for more information

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