Novacyt S.A. confirms IVDR accreditation under the new EU requirements of theIn 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 patientswithDihydropyrimidine Dehydrogenase (DPD) deficiency, through therapid 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 cancersincluding colorectal, head and neck, breast, pancreatic and stomach cancer. An estimated two million people globally are treated with fluoropyrimidines (including 5-FU) each year, with between 10-30% of these patients suffering severe side effects associated with DPD deficiency.

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.