Our Valued Sponsors & Partners
Manchester, UK, 29 September 2022: Yourgene Health plc (“Yourgene”, AIM: YGEN), a leading international molecular diagnostics group, today announced it has received Health Sciences Authority (HSA) approval for its IONA® Nx NIPT Workflow in Singapore. The prenatal screening workflow has been authorised for use in clinical laboratories, providing them with a fully automated and cost-effective testing solution to establish their own fast, accurate and quality-assured non-invasive prenatal testing (NIPT) service. Yourgene’s optimised NIPT solution enables efficient workflows, helping to save laboratories time, money and enhance their performance.
The IONA Nx NIPT Workflow is an in vitro diagnostic (IVD) tool designed to offer flexibility, simplicity and scalability for prenatal screening. The fully validated workflow uses next-generation sequencing (NGS)-based whole genome analysis to screen for a wide range of clinical conditions in the fetus, including Down’s syndrome (Trisomy 21), Edwards' syndrome (Trisomy 18) or Patau’s Syndrome (Trisomy 13). It can also be used to screen for autosomal- and sex-chromosome aneuploidies, as well as providing the option of fetal sex determination from 10 weeks gestation. The complete workflow includes sample preparation, DNA extraction and library construction, requiring minimal fetal fraction, as well as sequencing analysis and clinical reporting with full sample traceability.
The approval of the workflow in Singapore will help to expand patient access to non-invasive prenatal screening and provide laboratories with choice as to which IVD NIPT services they are able to offer clinicians. The regulatory authorisation adds to the IONA Nx’ existing accreditations, including a CE mark, and now means the workflow is available in many countries across Europe, the Middle East and Asia.
Rob Henke, PhD, Vice President of Sales, Asia Pacific, Yourgene Health, said: “By expanding into Singapore’s market, we are able to provide more laboratories access to our technology and, ultimately, offer more patients NIPT as a first call over higher risk procedures. Expanding further into Asia, with the help of our distributor SDT Molecular, is an exciting milestone for Yourgene, as we continue to establish new revenue opportunities and grow our international customer base.”
Shirley Tan, CEO of SDT Molecular, added: “We are honoured to be given the opportunity to help Yourgene obtain HSA approval for their IVD NIPT solution in Singapore. This marks an important milestone for SDT Molecular and we look forward to working closely with Yourgene, to allow more clinical laboratories in the region to benefit from this IVD offering.”
For more information on IONA Nx NIPT Workflow, please visit: https://www.yourgene-health.com/nipt/iona-nx
Notes to Editors
IONA Nx NIPT Workflow
Rob Henke, PhD, Vice President of Sales, Asia Pacific, Yourgene Health
For high-resolution images please contact Zyme Communications.
Yourgene Health
Jo Cross
Tel: +44 (0)7587 140 199
Email: joanne.cross@yourgene-health.com
Zyme Communications
Dr Michelle Ricketts
Tel: +44 (0)7789 053 885
Email: michelle.ricketts@zymecommunications.com
To opt-out from receiving press releases from Zyme Communications please e-mail info@zymecommunications.com. To view our privacy policy, please click here.
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 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, Singapore, the US and Canada, 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 and LinkedIn: Yourgene Health