NEW YORK — Novacyt said on Tuesday that it has received In Vitro Diagnostic Regulation (IVDR) accreditation in the EU for its DPYD genotyping assay for chemotoxicity.
The Yourgene DPYD assay is designed to identify cancer patients with dihydropyrimidine dehydrogenase (DPD) deficiency. The deficiency causes several and sometimes lethal side effects in patients treated with 5-fluorouracil, which is metabolized by the DPD enzyme, encoded by the DPYD gene. The CE-marked test uses fluorescent amplification refractory mutation system, or ARMS, allele-specific amplification technology to detect six clinically relevant variants in the DPD enzyme and was developed by Yourgene, which UK-based Novacyt acquired earlier this year.
According to Novacyt, the test 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.
"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," Novacyt acting CEO James McCarthy said in a statement.