IVDR certification for DPYD genotyping assay

Paris, France, and Eastleigh and Manchester, UK - 7 November 2023 - Novacyt S.A. (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, confirms IVDR accreditation under the new EU requirements of the In Vitro Diagnostic Regulation ("IVDR") for its DPYD genotyping assay, which supports the identification of cancer patients at risk of suffering a severe, and potentially life-threatening, reaction to common chemotherapy.

The Yourgene® DPYD assay is used to identify patients with Dihydropyrimidine Dehydrogenase (DPD) deficiency, through the rapid detection of six clinically relevant variants in the DPD enzyme. Patients with a DPD deficiency have a high risk of severe, and sometimes lethal, side effects following the administration of 5-Fluorouracil (5-FU), a widely used chemotherapy agent used in the treatment of many cancers including colorectal, head and neck, breast, pancreatic and stomach cancer.

An estimated two million people globally are treated with fluoropyrimidines (including 5-FU) each year1, with between 10-30% of these patients suffering severe side effects associated with DPD deficiency2. DPYD genotyping for 5-FU toxicity has been adopted in many countries internationally with screening introduced into cancer care clinical pathways following government reimbursement in England, Wales, Germany, Spain, Belgium and the Ontario province of Canada. The screening enables clinicians to reduce the risk of increased toxicity from 5-FU exposure in these patients by treatment with a lower dose, or with an alternate drug therapy where indicated.

The Yourgene® DPYD assay is a Class C in vitro medical device under IVDR and is intended for use by healthcare professionals within a molecular or oncology laboratory environment.

The new IVDR ensures that in vitro diagnostic devices manufactured for sale in the EU are assessed against stringent quality, safety and performance requirements. Manufacturers must provide, among other things, considerable evidence of scientific validity, as well as data demonstrating analytical and clinical performance of the devices. The DPYD assay was assessed by BSI, an independent conformity assessment body (the "Notified Body") and was shown to conform to the new regulations.

The DPYD assay is the first product within the now enlarged Novacyt product portfolio to conform to the new EU IVDR and is one of the first pharmacogenomics tests in the market, and the only assay for the rapid detection of the six clinically relevant variants in the DPD enzyme, as defined by the CPIC* guidelines, to conform to IVDR. The Directors of Novacyt believe that conformity with IVDR provides clinicians and patients with additional confidence in the high-quality and accuracy of this test, which is increasingly becoming an essential screening requirement ahead of cancer patient treatment.

Commenting James McCarthy, Acting Chief Executive Officer, said: "We are delighted to announce the first conformity of one of our products to the new EU regulations for in vitro diagnostic products. This success reflects the high-quality of the product in terms of both performance and safety, and follows a rigorous review by our Notified Body. It is a clear market advantage to have our product as the first assay to detect DPD deficiency to conform to IVDR, particularly as more and more countries in Europe and elsewhere are adopting this form of screening as their recommended procedure ahead of chemotherapy treatment."

Sources

1 D. Meulendijks et al./Cancer Treatment Reviews 50 (2016) 23-34

2 Cancer Research UK https://bit.ly/2kLn1uT

*CPIC Guidelines (Clinical Pharmacogenetics Implementation Consortium) provides clinical dosing recommendations based on DPYD genotype for patients https://cpicpgx.org/guidelines/guideline-for-fluoropyrimidines-and-dpyd/