Novacyt launches IVDR-certified Yourgene Insight DPYD assay in Europe
Novacyt has commercially launched the IVDR-certified Yourgene Insight DPYD assay across regulated European markets to support identification of patients at increased risk of severe fluoropyrimidine toxicity.
The molecular diagnostic detects 19 clinically relevant DPYD variants associated with dihydropyrimidine dehydrogenase deficiency and is intended to support safer use of fluoropyrimidine-based chemotherapy.
The launch completes the assay's transition from its research-use-only version introduced in May 2026 to compliance with the European Union's In Vitro Diagnostic Regulation.
Field | Content |
Alert Type | Approval |
Product Name | Yourgene Insight DPYD assay |
Company | Novacyt |
Regulatory Framework | European Union In Vitro Diagnostic Regulation (IVDR) |
Approval Type | IVDR certification and commercial launch |
Intended Use | Detection of clinically relevant DPYD variants associated with increased risk of severe toxicity from fluoropyrimidine-based chemotherapy |
Variants Detected | 19 clinically relevant DPYD variants |
Therapy Area(s) | Oncology; pharmacogenomics; molecular diagnostics |
Geography | European regulated markets |
What Happened | Novacyt commercially launched the IVDR-certified Yourgene Insight DPYD assay following completion of its regulatory transition under the European Union's IVDR. |
Why It Matters | DPYD genotyping can identify patients at increased risk of severe or potentially fatal toxicity from fluoropyrimidine chemotherapy, enabling treatment decisions to be adjusted before therapy begins. |
Supporting Context | The assay was initially launched for research use only in May 2026 and expands the number of detectable DPYD variants to 19. |
Key Takeaway | Novacyt has moved its expanded DPYD pharmacogenomic assay into regulated European clinical markets with IVDR certification. |
What to Watch | Adoption of DPYD testing across European oncology pathways and expansion into additional regulated territories. |
Primary Source | Novacyt |
Relevant Date | 8 September 2026 |
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