Company Announcements

Yourgene Health plc

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

US distribution agreement for DPYD and other products

Manchester, UK - 21 September 2020: Yourgene (AIM: YGEN), the international molecular diagnostics group, announces that it has appointed Immuno-Biological Laboratories Inc ('IBL-America'), a supplier of in-vitro diagnostic kits for the medical device and research industry, as a non-exclusive distributor for several PCR ('polymerase chain reaction') tests across Yourgene's reproductive health and oncology portfolios in the US.  

The distribution agreement initially includes the Elucigene® DPYD assay, which tests whether cancer patients can be at risk of significant and potentially lethal side effects caused by the 5FU chemotherapy treatment. In the US, there are approximately 500,000¹ 5FU chemotherapy treatments carried out per annum. Following the launch of the CE marked Elucigene DPYD in Europe, Yourgene now has over 20 hospitals and cancer centre customers routinely using the DPYD assay. As announced on 14 February 2020, the Company also has approval from the Therapeutic Goods Administration ('TGA') in Australia to allow the Company's Australian distribution partner, Southern Cross, to market and distribute the product in Australia.

In addition to the DPYD assay, the Company's cystic fibrosis, male factor infertility and invasive aneuploidy diagnostic products will also be sold by IBL-America which, together with the DPYD assay, represents what the Company believes to be an addressable market of over £30m per annum. Yourgene's products will initially be sold as Research Use Only ('RUO') to the research sector and to CLIA-certified laboratories for in-house validation prior to clinical use, with the potential for full FDA registration later depending on customer demand.  Minneapolis-based IBL-America has been providing high quality laboratory reagents to the US research and clinical markets for over 20 years with a focus on customer and product support.

Lyn Rees, CEO of Yourgene, commented: "The appointment of IBL-America is an important pillar within our plans to penetrate the largest diagnostics market in the world with our full portfolio across the whole genomic testing lifecycle. We have a strong pipeline of US-oriented product and technology partnerships and look forward to updating investors as these opportunities crystallise."

¹https://fennecpharma.com/wp-content/uploads/2014/01/Eniluracil-Way-Forward-2014.pdf

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

About Yourgene Health plc

Yourgene 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, for reproductive health and molecular genetics. 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 is also extending its genetic testing offering into oncology.

Yourgene 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.