19 March 2021 – Twin Pregnancy study published using Yourgene’s IONA® Test

Yourgene Health plc

(“Yourgene” or the “Group” or the “Company”)

Twin Pregnancy study published using Yourgene’s IONA® Test

Manchester, UK – 19 March 2021: Yourgene (AIM: YGEN), the international molecular diagnostics group, welcomes the paper published in the American Journal of Obstetrics and Gynecology by Khalil et al., titled: “Non-invasive Prenatal Screening in Twin Pregnancies with cell-free DNA using the IONA® Test: a prospective multicentre study.”

The article details a multicentre study that took place in six fetal medicine centres across the UK, using Yourgene’s IONA® test to establish the screening performance of cell-free DNA (cfDNA) for the three common trisomies in twin pregnancies. The study confirmed that cfDNA testing is the most accurate screening test for trisomy1 21 in twin pregnancies, with screening performance similar to single pregnancies, and failure rates of just 0.31%. It was concluded that the predictive accuracy for trisomies 18 and 13 may be lower than for trisomy 21 but, given the low false positive rate, it was determined that offering first line screening of cfDNA to women with twin pregnancies is appropriate and should be considered as the primary screening test for trisomies in twin pregnancies as well as in single pregnancies.

The study is a positive development as previously several organisations have recommended against cfDNA in twin pregnancies, calling for larger prospective studies, despite the potential advantages of non-invasive prenatal testing (NIPT) in twin pregnancies being even greater than in single pregnancies. The multicentre study was carried out with six leading NHS fetal medicine centres in England. The lead author, Dr Asma Khalil, is a global expert in twin pregnancies, based at St George’s University Foundation Hospital NHS Trust in South London. Yourgene has an existing relationship with St George’s NHS Trust Foundation for its IONA® Nx NIPT Workflow, which underpins their own brand NIPT, the “St George’s Antenatal Fetal Evaluation (SAFE) Test” which is run in their own lab.

Read the full paper here: https://www.sciencedirect.com/science/article/pii/S0002937821000284

Lyn Rees, CEO of Yourgene, commented: “It is great to have the clinical validation of NIPT screening in twin pregnancies fully recognised. NIPT lowers the need for invasive testing and the consequent fetal loss rate, providing a safer option for expectant mothers, especially in twin pregnancies. The study concluded that NIPT should be considered as the primary test and part of the clinical pathway for all pregnancies, an important milestone for non-invasive testing which confirms the key advantages of our IONA® Test.”

1 – Trisomy – a condition in which an extra copy of a chromosome is present in the cell nuclei, causing development abnormalities

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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 primarily develops, manufactures, and commercialises simple and accurate molecular diagnostic solutions, for reproductive health, precision medicine and now infectious diseases. The Group’s flagship products include non-invasive prenatal tests (NIPT) for Down’s Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests, and a recent extension into the oncology space with DPYD genotyping.

The launch of Yourgene Genomic Services has enabled Yourgene to offer a global laboratory service network equipped to be a full life-cycle partner for clinical, research and pharmaceutical organisations to support partners at the preclinical, clinical, and post-market stages to develop, manufacture, obtain regulatory approval and commercialise new products and services. In addition, Yourgene Genomic Services offers an NIPT and high throughput COVID testing service.

In August 2020, Yourgene acquired Coastal Genomics, Inc., a sample preparation technology company based in Vancouver, Canada, enabling the Company to extend its offering and IP portfolio in the DNA sample preparation sector. The acquisition increased Yourgene’s geographical penetration into the US and Canada, supplementing existing coverage in the UK, Europe, MEA and Asia.

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.