Launch of DPYD chemotoxicity diagnostic assay

Yourgene Health plc

("Yourgene" or the "Company")

Launch of DPYD chemotoxicity diagnostic assay

Test to identify cancer patients at risk of lethal side effects from chemotherapy

Manchester, UK - 18 September 2019: Yourgene (AIM: YGEN), a leading international molecular diagnostics group, announces the launch of the Company's first oncology product, the Elucigene DPYD assay ("Elucigene DPYD"), a new chemotoxicity diagnostic assay.  

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.

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, and up to 1% of patients treated with 5-FU are estimated to die as a result of DPD deficiency². Once identified using genotyping treatment can be personalized for that patient, potentially reducing the incidence of hospital admission and preventing rare and unnecessary deaths associated with 5-FU toxicity.

Elucigene DPYD conforms with the Clinical Pharmacogenetics Consortium Guidelines, published in 2017 for DPYD genotyping, which recommends testing for four clinically relevant mutations, which are all covered by the Company's comprehensive test for six common types of genetic variations. The CE marked test kits offers laboratories a simple-to-use product which provides reliable and accurate detection, with a rapid turnaround time. For the full customer brochure see here:

http://www.rns-pdf.londonstockexchange.com/rns/6811M_1-2019-9-17.pdf

Lyn Rees, CEO of Yourgene, commented:

"This product launch marks a number of firsts for Yourgene. This is the first new test kit launched since the acquisition of Elucigene earlier this year, and is a testament to the smooth and successful integration of the two businesses. It is also our first product in the area of oncology, which delivers on our strategy to expand our product portfolio and bring new products to market. This is also our first product in the area of pharmacogenomics, an exciting medical field that looks at how genes impact upon a patient's response to drugs, and so we are very pleased to be addressing a broader market within Precision Medicine."

About the Bionow Precision Medicine Conference

Elucigene DPYD is being launched today at the Bionow Precision Medicine Conference at Citylabs 1.0 in Manchester. The conference which brings together the UK's leading experts in the area of Precision Medicine, an emerging area of healthcare research that uses an individual's genetic profile to guide decisions about the prevention, diagnosis and treatment of disease. Dr Stephen Little, Vice Chair and Founder of Yourgene Health is speaking in a session focused on "Precision Medicine in oncology." For more information on the conference visit:

https://bionow.co.uk/event/Bionow012/bionow-precision-medicine-conference

Notes

1. D. Meulendijks et al./Cancer Treatment Reviews 50 (2016) 23-34

2. Cancer Research UK https://bit.ly/2kLn1uT

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.