Yourgene-Health

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.

Updated 16 November 2023

We did not rate this service. This is because CQC does not apply a rating to independent laboratory services.

• The service did not have an effective process for carrying out checks on company directors in line with regulatory requirements for fit and proper persons who were directors.
• Leaders did not always carry out relevant checks for employed staff as part of their recruitment processes.
• The service did not have clear guidance for mandatory training.
• The service did not have in date assessments for fire, electrical appliances, or hazardous substances.

However:

• The service had enough staff to provide the right level of service. Staff had training in key skills and managed safety incidents well and learned lessons from them.
• The service was planned to meet the needs of people using their service and made it easy for people to contact the service when needed and receive laboratory results promptly.
• Leaders ran services well using reliable information systems and supported staff to develop their skills. Staff felt respected, supported, and valued. Staff were clear about their roles and accountabilities. All staff were committed to improving services continually.

Updated 16 November 2023