Yourgene Health plc
(“Yourgene” or the “Group” or the “Company”)
Yourgene Health Presents Data Demonstrating Successful Fetal Fraction Enrichment in NIPT Workflows Following Prolonged Blood Storage in EDTA Tubes
- Extended EDTA blood tube storage offers improved flexibility and cost-saving in NIPT workflows
- Collaborative study with Tommy’s Charity and St Mary’s NHS Hospital, Manchester
- Data presented at ISPD 2023 in Edinburgh, UK
Manchester, UK, 19 June 2023: Yourgene Health plc (“Yourgene”, AIM: YGEN), a leading international molecular diagnostics group, today presented data demonstrating that prolonged storage of blood in EDTA tubes is compatible with non-invasive prenatal testing (NIPT) when using size selection to enrich the fetal fraction. Scalable and precise DNA size selection following EDTA tube usage offers a cost-efficient alternative to the use of more expensive blood collection tubes (BCTs) and improves next-generation sequencing (NGS) workflows, reducing the risk of failed screening tests for expectant mothers. The data is currently being presented at the 27th International Conference on Prenatal Diagnosis and Therapy (ISPD) in Edinburgh, UK on 19th June 2023.
The collaborative study with Tommy’s Charity and St Mary’s NHS Hospital (Manchester, UK) used Yourgene’s IONA® Nx NIPT Workflow, a fully validated clinical workflow which utilises NGS to estimate the trisomy risk in the fetus. The workflow incorporates the unique size-selection capability of the company’s proprietary Ranger® Technology to collect DNA library material within a defined size range. This step enriches the fetal-derived cell-free DNA (cfDNA) fragments in samples by reducing the number of larger maternal DNA fragments. In addition, Yourgene has a patent pending in relation to the EDTA capability that has been filed.
Many NIPT clinics and hospitals take a maternal blood sample with an expensive BCT, such as a Streck tube, and the sample is stable for up to 14 days. However, the data presented has shown the capability to use EDTA tubes, which are commonly used and a significantly lower cost, with proven stability up to 7 days.
Sample stability and handling are crucial elements in the preservation of acceptable levels of fetal fraction and ultimately, the successful use of NIPT. Cell lysis due to sample instability can result in the release of maternal genomic DNA, which dilutes the fetal-derived cfDNA, thereby reducing the fetal fraction. The results of the study demonstrate that size selection can be used to recover the fetal fraction from whole blood stored in EDTA tubes over a prolonged period that exceeds the previous limit of 8 hours.
Dr Joanne Mason, Chief Scientific Officer at Yourgene Health, said: “The results of Yourgene’s study with Tommy’s and St Mary’s Hospital greatly improve the feasibility of EDTA tube usage in NIPT, particularly in situations where delayed transport of samples between collection site and analysis locations may occur. There’s also a considerable saving in the cost of the blood stabilising tubes, and associated licensing fees in the US. This offers greater flexibility and choice to labs and clinicians, while providing patients with fast, safe, and accurate screening results.”
Visit the poster (programme ID P-94) titled “A study to demonstrate that prolonged storage of blood in EDTA tubes is compatible with NIPT when using size selection to enrich fetal fraction present” at ISPD taking place from 18–21 June. Copies of the poster will also be available to download from Yourgene’s website:
For more information about Yourgene’s IONA Nx NIPT Workflow and its proprietary Ranger Technology, visit: yourgenehealth.com/our-products/instruments/lightbench-detect
Notes to Editors
Dr Joanne Mason,
Chief Scientific Officer at
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About Yourgene Health www.yourgenehealth.com
Yourgene Health is an international integrated technologies and services business, enabling the delivery of genomic medicine. 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 and screening solutions, for reproductive health and precision medicine. The Group’s portfolio of in vitro diagnostic products includes non-invasive prenatal tests (NIPT) for Down’s Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests and DPYD genotyping assays.
Building on our expertise in genomic technology, Yourgene’s Ranger® Technology offers next generation size selection with a range of sample preparation platforms for dynamic target enrichment. Ranger® Technology can be utilised to improve workflows and performance in multiple applications including NIPT, oncology, infectious disease testing and gene synthesis.
Yourgene Genomic Services offers a clinical service from the UK focusing on precision medicine and reproductive health, including NIPT.
Yourgene Health is headquartered in Manchester, UK with offices in Singapore, the US and Canada, and is listed on the London Stock Exchange’s AIM market under the ticker “YGEN”.