Updated 16 November 2023
Yourgene Health is a genomic services medical laboratory within Yourgene Health UK Limited which provides a non-invasive prenatal screening test (NIPT) for pregnant women using their own CE marked IONA test. CE marked certifies that a product has met EU health, safety, and environmental requirements. They also provide, out of CQC’s regulatory scope, genomic services for example covid testing and clinical research support services. The Yourgene genomic services laboratory is managed as a separate department within Yourgene Health and in line with this has its own quality management system. Yourgene Health’s other activities include reagent kit and instrumentation manufacturing. The activities other than NIPT do not come under CQC’s Scope of Registration and therefore were not inspected.
The NIPT assay estimates the risk of a foetus being affected with Trisomy 21 (Down’s syndrome), Trisomy 18 (Edwards’ syndrome) or Trisomy 13 (Patau’s syndrome). Where requested, the assay also provides additional screening of sex determination, sex chromosome aneuploidy and autosomal aneuploidy. Yourgene Health was registered with CQC on 1 June 2022. Previously they operated under the name of City Labs and later Premaitha Health which was registered in 2015 with CQC.
Yourgene Health does not have direct contact with patients/customers. They have service level agreements with companies to provide NIPT testing for their patients/customers. They receive the blood sample from the companies via post or courier.
Yourgene genomic services is accredited with the United Kingdom Accreditation Service (UKAS) standards ISO 15189 for the NIPT service and Covid testing. The United Kingdom Accreditation Service (UKAS) is recognised by the government as the sole national accreditation body.
The service is regulated to provide diagnostic and screening procedures and there is a registered manager in post.