Prenatal Screening Tool HSA approved for use in Singapore

International molecular diagnostics group Yourgene Health, has received Health Sciences Authority (HSA) approval for its IONA® Nx NIPT Workflow in Singapore. The IVD tool offers screening for a wide range of clinical conditions in the prenatal foetus, including Down’s syndrome (Trisomy 21), Edwards' syndrome (Trisomy 18) or Patau’s Syndrome (Trisomy 13) and can also be used to screen for autosomal- and sex-chromosome aneuploidies.

The approval of the workflow in Singapore will help to expand patient access to non-invasive prenatal testing (NIPT) 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.”

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