Updated 12 January 2026
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.