MANCHESTER: Yourgene Health, an international molecular diagnostics group, announced that its chemotoxicity diagnostics assay – Elucigene DPYD – which tests to identify cancer patients at risk of lethal side effects from chemotherapy, has been approved for sale in Australia by the Therapeutic Goods Administration (TGA) as an IVD (in vitro diagnostic).
The TGA is the regulatory body for therapeutic goods in Australia. It is a Division of the Australian Department of Health established under the Therapeutic Goods Act 1989.
In September 2019, Yourgene announced the launch of Elucigene DPYD assay (“Elucigene DPYD”), the Company’s first oncology product. It 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 metabolised by the DPD enzyme which is encoded by the DPYD gene.
It is estimated that globally over 2 million people are treated with 5-FU every year and of these up to 20% will be hospitalised due to DPD deficiency and up to 1% may die.
The Elucigene DPYD will be sold via Yourgene’s Australian distribution partner, Southern Cross. Southern Cross has more than 30 years’ experience in the human diagnostic and medical device industry in Australia focusing mainly on Infections Diseases and molecular diagnostics. Southern Cross will arrange for the registration of the product and will be Yourgene’s sole distributor in the Territory.
Lyn Rees, CEO of Yourgene, commented: “We are extremely pleased to address another market with our first oncology test which has already seen traction in the UK and Europe since its launch in September 2019, and reinforces our strategic plans of product penetration and geographic expansion. We are looking forward to working with our distribution partners, Southern Cross, to be able to support oncologists and their patients in Australia with DYPD screening ahead of 5-FU treatment.”
Edited by Nayyar Iqbal