Novacyt (LSE AIM:NCYT), the molecular diagnostics group, announced the commercial launch of its In Vitro Diagnostic Regulation (IVDR)-certified Yourgene Insight DPYD assay.
The certification follows the assay's introduction as a Research Use Only product in May and completes its regulatory transition to full IVDR compliance, broadening the commercial opportunity across highly regulated European markets.
The assay detects 19 clinically relevant variants in the DPYD gene, helping identify patients at higher risk of severe toxicity from fluoropyrimidine-based chemotherapy.
Novacyt said it is the first CE-marked, IVDR-compliant DPYD assay to incorporate all current Tier 1 and Tier 2 variants recommended by the Association for Molecular Pathology and the National Comprehensive Cancer Network.
"By delivering the first IVDR-certified DPYD assay incorporating all recommended Tier 1 and Tier 2 variants, we are providing laboratories with a comprehensive solution that aligns with the latest clinical guidance", said Lyn Rees, chief executive officer.
The launch adds to Novacyt's clinical genetics portfolio, which sits within a broader diagnostics business spanning reproductive health, infectious disease and precision medicine testing.
The company has expanded its international footprint recently too, acquiring Southern Cross Diagnostics in March, which opened new distribution channels across Australia and the wider Asia-Pacific region.
