Yourgene Health plc
(“Yourgene” or the “Group” or the “Company”)
DPD reimbursement in Germany
Manchester, UK – 24 September 2020: Yourgene (AIM: YGEN), the international molecular diagnostics group, announces that the German Federal Joint Committee, G-BA, the national reimbursement authority in Germany, has approved the reimbursement for testing of Dihydropyrimidine Dehydrogenase (DPD) deficiency in Germany, which opens up the clinical market in this region for the Company’s first oncology genotyping product, the Elucigene DPYD Test. The preliminary reimbursement figure for DPD testing is set at 120 EUR for each patient test. The scheme commences on the 1 October 2020 and has not at this stage specified any commercial products or technologies.
Elucigene DPYD is a simple-to-use genotyping test that can identify cancer patients with Dihydropyrimidine Dehydrogenase (DPD) deficiency, which can cause severe and sometimes lethal side effects in patients being treated with chemotherapeutic drug 5-Fluorouracil (5-FU), commonly used in the treatment of colon, oesophageal, stomach, pancreatic, breast and cervical cancers. 5-FU is metabolized by the DPD enzyme which is encoded by the DPYD gene.
The Committee for Risk Assessment in the field of pharmacovigilance of the European Medicines Agency and the Federal Institute for Medicinal Products and Medical Devices have determined the benefits of the DPD test, highlighting patients with an absence or deficiency of the DPD enzyme to have an increased risk of severe or life threatening toxicity. The reimbursement will fall under the EBM scheme, which covers the largest number of patients (approx. 80% of the population).
Lyn Rees, CEO of Yourgene Health said: “We expect this reimbursement approval to help accelerate our growth in this key market, aided by having a direct sales presence, enabling us to capitalise on this opportunity.”
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
Yourgene Health plc
Lyn Rees, Chief Executive Officer
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About Yourgene Health
Yourgene Health is an international molecular diagnostics group which develops and commercialises genetic products and services. The group works in partnership with global leaders in DNA technology to advance diagnostic science.
Yourgene develops and commercialises simple and accurate molecular diagnostic solutions, primarily for reproductive health. The Group’s products include non-invasive prenatal tests (NIPT) for Down’s Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests, male infertility tests and genetic disease tests. Yourgene’s commercial footprint is already established in the UK, Europe, the Middle East, Africa and Asia.
Our product development, research service and commercial capabilities extend across the lifecycle of genetic test development including regulatory submissions. Through our technical expertise and partnerships, Yourgene Health is also extending its genetic testing offering into oncology.
Yourgene Health is headquartered in Manchester, UK with offices in Taipei and Singapore, and is listed on the London Stock Exchange’s AIM market under the ticker “YGEN”. For more information, visit www.yourgene-health.com and follow us on twitter @Yourgene_Health.