YGEN.L Regulatory News (YGEN)

Yourgene Health plc

("Yourgene", the "Company")

Yourgene launches Sage™ 32 plex

High throughput NIPT solution for clinical laboratories

Manchester, UK - 8 January 2019: Yourgene Health (AIM: YGEN), the international molecular diagnostics group which commercialises genetic products and services, is pleased to announce the launch of the Sage™ 32 plex test, a new high throughput non-invasive prenatal testing ("NIPT") and analysis solution for clinical laboratories.

Sage™ 32 plex uses the latest technology to detect placental DNA in a maternal blood sample, enabling pregnant women to get fast, safe and reliable test results, and reducing the number of women needing to undergo invasive follow-up tests with associated risks. The Sage™ 32 plex solution significantly improves efficiency, enabling up to 32 samples to be processed in one sequencing run, compared with just 12 samples previously. This will provide laboratories with enhanced flexibility, scalability and cost-effectiveness, while retaining all the high qualities of the existing Sage™ prenatal screen test.

A combination of both workflow improvements and upgraded analysis methods have been incorporated to improve the test's overall performance and efficiency, with the addition of the new Yourgene QS250 instrument into the workflow.

The higher throughput test runs on ThermoFisher's Ion Torrent sequencing technology and will be available internationally. Yourgene plans to launch a CE-IVD marked version of the library preparation kit that is used in the Sage™ 32 plex workflow in the coming months.

Yourgene provides two complementary screening solutions, Sage™ and the IONA® test (CE-IVD), to meet the requirements of laboratory customers, clinicians and pregnant women across different international locations.

The Sage™ prenatal screen differs from the IONA® test in that it offers screening on a wider range of clinical conditions, including trisomy 21, trisomy 18 and trisomy 13, sex chromosome aneuploidies and some clinically relevant microdeletions. The analysis element is undertaken via a cloud-based bioinformatics and software solution called Sage™ Link, which has been enhanced with additional features and an improved user-friendly interface.

Lyn Rees, CEO of Yourgene Health, commented: "This latest product launch from Yourgene is an important enhancement of our Sage™ solution. Many territories around the world - particularly developing NIPT markets - need the scalability and cost-efficiencies of a higher throughput NIPT solution that does not compromise on quality. With Sage™ 32 plex, we are almost trebling the throughput, making it a highly efficient solution for our international laboratory network which we are very excited to commercialise.

"I look forward to providing additional updates as we continue to develop and extend our product portfolio."

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. 

Our product development, research service and commercial capabilities extend across the lifecycle of genetic test development including regulatory submissions.

Yourgene Health's first commercialised products are non-invasive prenatal tests (NIPT) for Down's syndrome and other genetic disorders, targeting a share of an emerging billion-dollar global market.

Prenatal screening is an established clinical practice, but accuracy challenges with traditional methods are driving the need for NIPT and other DNA-based reproductive health testing solutions. Yourgene Health's customer-focused products and services support all types of customer, irrespective of size, geography and market maturity. Our commercial footprint is already established in the UK, Europe, the Middle East, Africa and Asia.

Through our technical expertise and partnerships, Yourgene Health is aiming to extend its genetic testing offering into complementary areas of reproductive health and oncology.

Yourgene Health is headquartered in Manchester, UK with offices in Taipei and Singapore. For more information visit www.yourgene-health.com and follow us on twitter @Yourgene_Health.