The Care Quality Commission
  • Hospital
  • Independent hospital

Yourgene-Health

Irwell Place, Manchester Science Park, Lloyd Street North, Manchester, M15 6SH (0161) 669 8122

Provided and run by:
Yourgene Health UK Ltd

All Inspections

During an assessment under our new approach

We carried out a short, announced inspection on 16 January 2026 to follow up on breaches identified in our 2023 inspection. We assessed 3 quality statements from the safe key question, 2 quality statements from the effective key question and 1 quality statement from the well-led key question.

Yourgene-Health were not rated since we do not rate pathology laboratories. They delivered one service type which we assessed: diagnostic and screening.

Since our last inspection, Yourgene-Health UK Ltd have become part of the Novacyt Group. They provide comprehensive non‑invasive prenatal screening (NIPT) for genetic conditions using their own CE‑marked IONA testing; CE marking confirms that a product meets EU health, safety, and environmental standards.

The Yourgene-Health genomic services laboratory is managed as a separate department and has its own staff and quality management system. The NIPT screening they carry out estimates the risk of a foetus being affected with Trisomy 21 (Down’s syndrome), Trisomy 18 (Edwards’ syndrome) or Trisomy 13 (Patau’s syndrome), Turner, Triple X, Klinefelter and Jacobs syndromes. With the recent launch of IONA Care+, they now also screen for DiGeorge Syndrome, Prader-Willi, Angelman, 1p36 deletion, Cri-du-Chat and Wolf-Hirschhorn Syndrome. Where requested, the screening can also provide sex determination.

Yourgene-Health UK Ltd.’s other activities include reagent kit and instrumentation manufacturing. These activities do not come under CQC’s Scope of Registration and therefore were not inspected.

They have service level agreements with clinics to provide NIPT testing for their patients. They receive the blood sample from the clinics via post or courier. Yourgene-Health genomic services is accredited with the United Kingdom Accreditation Service (UKAS) standards ISO 15189 for the NIPT service. The United Kingdom Accreditation Service (UKAS) is recognised by the government as the sole national accreditation body.

Yourgene-Health does not have direct contact with patients.

We inspected the pathology laboratories where the NIPT testing took place and spoke with 6 staff: including the registered manager (also the laboratory director), laboratory manager, quality assurance manager, health and safety assistant manager, clinical team leader and 1 scientist. We looked at 2 training files and 6 recruitment files. We looked at a range of policies, procedures and other documents relating to the running of the service.

At our previous inspection, the service was in breach of legal regulation in relation to mandatory training, recruitment processes and safe environment. At this inspection we found the provider met the regulations for the environment and mandatory training. However, we found a continued breach in regulation 19 in respect of recruitment.

12 July 2023

During a routine inspection

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.