YGEN.L Regulatory News (YGEN)

Yourgene Health plc

("Yourgene" or the "Group" or the "Company")

TGA approves DPYD for sale in Australia

Southern Cross, Yourgene's Australian distributor, to sell the chemotoxicity diagnostic assay in the Territory

Manchester, UK - 14 February 2020: Yourgene (AIM: YGEN), a leading international molecular diagnostics group, announces 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 ('the Territory') 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."

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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.