Therapy Areas: Infectious Diseases
Novacyt attains IVDR certification for DPYD genotyping assay
7 November 2023 -

Diagnostics company Novacyt (EURONEXT GROWTH: ALNOV) (AIM: NCYT) announced on Tuesday that it has achieved In Vitro Diagnostic Regulation (IVDR) accreditation for its DPYD genotyping assay, a critical step in identifying cancer patients at risk of severe reactions to common chemotherapy. The assay, conforming to stringent EU requirements, is one of the first products of its kind to align with the new IVDR standards.

The Yourgene DPYD assay rapidly detects Dihydropyrimidine Dehydrogenase (DPD) deficiency in patients, crucial for assessing the risk of severe reactions to the chemotherapy agent 5-Fluorouracil (5-FU). Approximately 10-30% of the two million patients globally treated with fluoropyrimidines, including 5-FU, experience severe side effects associated with DPD deficiency.

The DPYD assay's IVDR conformity, assessed by BSI, enhances confidence in its high-quality and accuracy. It is the first product in Novacyt's expanded portfolio to comply with IVDR, standing out as one of the first pharmacogenomics tests in the market.

Novacyt delivers a comprehensive range of in vitro and molecular diagnostic tests for infectious diseases, offering seamless sample-to-result workflows. The acquisition of Yourgene in September 2023 adds complementary genomics technology and services to Novacyt's portfolio, focusing on reproductive health and precision medicine. Headquartered in France, Novacyt has offices in the UK, Taipei (divestment pending), Singapore, the US and Canada.