RE: DPYD Test14 May 2026 09:34
IVDR Compliance: With the enforcement of the European Union's In Vitro Diagnostic Regulation (IVDR), manufacturers must provide robust, clinical evidence supporting the safety and validity of their diagnostic kits. Consequently, industry players like Novacyt/Yourgene Health have driven market growth by securing IVDR certification for their specialized DPYD assays.
Key Providers: Major players in this market offer targeted SNP detection (Single Nucleotide Polymorphisms) or sequencing assays. Prominent companies in the space include Yourgene Health (Novacyt), Roche (LightMix kits), Tempus, and LGC Clinical Diagnostics, which also produces mutation controls.
Test Economics: The retail cost of an individual DPYD genetic test generally ranges between \(\$100\) and \(\$300\), yielding an excellent cost-to-value ratio for oncology departments and pathology labs