Company Announcements

Yourgene Health plc

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

IONA® Nx Launch

Manchester, UK - 3 September 2020: Yourgene (AIM: YGEN), the international molecular diagnostics group, announces the launch of IONA® Nx NIPT workflow, the Company's new innovative non-invasive prenatal test ('NIPT'). The IONA Nx seeks to offer clinical labs a high performing, flexible, scalable and innovative NIPT service in-house and is developed to run on the Illumina Nextseq 550 Dx platform for next generation sequencing.

As announced on 15 June 2020, the IONA Nx received a CE mark across the European Union, including the UK, as well as other countries that accept the CE-IVD mark.  Yourgene will initially transition existing customers in the UK and France, where the Company has an existing direct presence to the IONA Nx.  The Company also expects to see uptake of the product in other European territories where it will utilise its recently strengthened commercial team in Europe.

In addition, Yourgene will be targeting additional markets within the Illumina IP territory following regulatory approvals.  As announced on 13 August 2020 Australia's Therapeutics Goods Association ('TGA') approved the IONA Nx as a medical device Class 3, allowing Southern Cross Diagnostics, Yourgene's Australian distributor, to commence sales.  Further territories covered by the Illumina licence agreement will also be made available when regulatory submissions are approved.

Illumina's NGS technology accounts for around 75% of the global NGS market and the NIPT market in Europe alone is set to grow to USD $500 million by 2025¹ which puts Yourgene in a strong position going forward. The Yourgene NIPT service laboratory in Manchester is in the process of changing over to the IONA Nx and Yourgene will inform customers when this is live.

About IONA Nx

The IONA Nx uses an innovative new fetal fraction enrichment step with the Yourgene QS250 instrument, which enriches fetal fraction by two-fold, reducing the need for as much sequencing and therefore making it a more cost effective NIPT workflow. The Yourgene QS250 is powered by the Ranger® technology, from Coastal Genomics which Yourgene acquired in August 2020. The use of the Yourgene QS250 in an NIPT NGS workflow is an industry step change, the instrument increases cell free fetal DNA enrichment which increases sequencing efficiency and improves the performance of NIPT.

The IONA Nx has a reduced capital footprint with new instrumentation in the workflow and uses the Yourgene SP150 and Yourgene QS250 to combine the DNA extraction, sample preparation and enrichment elements of the workflow ahead of the sequencing step. This is the first time Yourgene will be making the instruments commercially available as part of the workflow and enables customers to obtain the majority of the workflow, including instruments, reagents, bioinformatics software and workflow management systems, from one provider.

There are several unique and new product features to the IONA Nx including >99.99% accuracy (sensitivity and specificity) and an extended clinical menu, offering whole genome analysis including  Trisomy 21, 18, 13, Sex chromosomal aneuploidies,  other autosomal aneuploidies and optional fetal sex determination, with the intention to add clinically relevant Microdeletions in the near future. The IONA Nx is flexible and scalable which makes it suitable for automated or manual workflow with up to 48 samples per sequencing run and therefore suitable for low to high throughput labs. It is one of the fastest automated workflows on the market and can be performed in just two days, three for manual workflow. The Atlas Workflow Manager, developed by Yourgene, is available for the automated workflow to give complete traceability and can also be customised to integrate with a customer labs own laboratory information management systems ('LIMS').

For full details of the IONA Nx please visit: www.yourgene-health.com/nipt/iona-nx

Lyn Rees, CEO of Yourgene Health plc, stated: "We have already expanded our European sales team with key appointments in UK, France, Germany to support the commercial roll-out of the IONA Nx and we will look to give updates on key milestones such as regulatory approval and new customer wins. Our IONA test has a strong reputation for reliability and accuracy and was the first CE marked NIPT product for the European market.  The new IONA Nx combines this gold standard for reliability and accuracy with a market leading sequencer and we believe this will be a strong driver of growth in the future.

"We expect to see accelerated double-digit growth in our NIPT business this calendar year. We are confident that a this will be delivered through a mix of organic growth across our existing NIPT customer base, the transition of existing customers to IONA Nx in current territories, as well through securing new customers and commencing sales in new territories."

¹ https://www.prnewswire.com/news-releases/european-500-million-non-invasive-prenatal-testing-market-to-2025-300728591.html

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.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.