Novacyt

IVDR certification achieved for DPYD genotyping assay – First product of its kind to conform with new IVDR requirements

Home | News | Press Releases | IVDR certification achieved for DPYD genotyping assay – First product of its kind to conform with new IVDR requirements

IVDR certification achieved for DPYD genotyping assay

First product of its kind to conform with new IVDR requirements

Yourgene Health (part of the Novacyt group), an international specialist in clinical diagnostics, confirms – IVDR accreditation under the new requirements of the In Vitro Diagnostic Regulation (“IVDR”) for its DPYD genotyping assay, which helps identify 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 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 regulations 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, to conform to IVDR. The Directors 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 conformity of our first product 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.”

Learn more about Yourgene® DPYD: https://yourgenehealth.com/our-products/assays-and-applications/precision-medicine/dpyd-genotyping/

Sources
1 D. Meulendijks et al./Cancer Treatment Reviews 50 (2016) 23–34
2 Cancer Research UK https://bit.ly/2kLn1uT

Related Articles

Yourgene Health and Genetix Launch First Local Non-invasive Prenatal Testing Service in Colombia

3 October 2024

Yourgene Health and Genetix Launch First Local Non-invasive Prenatal Testing Service in Colombia Genetix will utilise Yourgene Health’s IONA Nx NIPT Workflow to deliver first NIPT service in region...
Read more Read more

Primerdesign Launches Real-time PCR Workflow for Onsite Detection of Norovirus in Oysters

25 June 2024

genesig Easy_oys Detection Kit offers rapid and reliable qPCR workflow to quantify Norovirus GI and GII pathogens in oyster tissue  Onsite analysis helps ensure shellfish quality and safety across...
Read more Read more

Yourgene Health Becomes a PacBio Compatible Partner: Enabling PacBio Customers to Optimise Size Selection for Long-Read Sequencing Libraries

17 November 2023

Yourgene Health Becomes a PacBio Compatible Partner: Enabling PacBio Customers to Optimise Size Selection for Long-Read Sequencing Libraries Yourgene’s LightBench® instrument offers precise and accurate target enrichment of PacBio HiFi...
Read more Read more

Yourgene Health and Laboriad Launch Non-invasive Prenatal Testing in Morocco

9 November 2023

Yourgene Health installs first NIPT platform, the IONA test, in Morrocco, enabling Laboriad to offer safe, fast and accurate prenatal testing to expectant parents Manchester, UK, and Rabat, MOROCCO,...
Read more Read more

Yourgene Health Launches MagBench Automated DNA Extraction Instrument and Kit for NIPT Workflows

5 September 2023

Yourgene Health Launches MagBench Automated DNA Extraction Instrument and Kit for NIPT Workflows Offers clinical labs in APAC and Middle East cost-efficient, bench-top robotic cell-free DNA extraction workstation and...
Read more Read more