Cambridge Cancer Laboratory Awarded Formal Accreditation as a Medical Laboratory
18 February 2026
The Cancer Molecular Diagnostics Laboratory (CMDL), which forms part of the Cancer Research UK Cambridge Centre, and receives funding from the Cambridge BRC, has been awarded the esteemed ISO 15189 accreditation by the United Kingdom Accreditation Service. Obtaining ISO accreditation is a significant achievement which acknowledges that the CMDL operates within internationally recognised standards of quality and reliability for medical laboratories.
The lab has been working towards accreditation for the last three years because new EU regulatory requirements mean that clinical trial results used to inform patient management must originate from an accredited laboratory. In order to meet the ISO standards, CMDL was required to build a new Quality Management System from the ground up and establish a dedicated Quality Lead role. The involvement of a new Clinical Oversight Group of practising clinicians and consultant clinician scientists at Cambridge University Hospitals was also critical for achieving the accreditation.
The CMDL was established several years ago to provide a range of laboratory services on clinical samples for clinical trials and research studies conducted across the Centre’s research themes. The lab’s work includes processing patient samples, sequencing DNA from patient samples, developing new molecular tests and data analysis.
A recent successful collaboration is the DIRECT study supported by the Mark Foundation Institute for Integrated Cancer Medicine. In addition to processing the blood and tissue samples from all sites in the study, the CMDL worked with study lead, Dr Dan Hodson and members of his research team to develop a new circulating tumour DNA assay to assess treatment response in patients with diffuse large B-cell lymphoma.
The newly awarded ISO accreditation will enable CMDL to continue delivering high-quality molecular diagnostics for national clinical trials and trials conducted in partnership with the Cancer Core Europe consortium. It removes the need for trial teams to repeat tests at external accredited laboratories, helping to preserve limited patient samples and streamline trial processes.
As one of the few ISO 15189‑accredited laboratories outside the NHS, CMDL can now provide researchers at the University of Cambridge and local start‑ups with access to accredited diagnostics that would otherwise require outsourcing to commercial providers at significantly higher cost.
Shubha Anand, CMDL Director, pictured below, said:
“I am incredibly proud of the whole team. Their hard work, commitment, and willingness to embrace new processes have been essential to making the Quality Management System function effectively.
This accreditation positions CMDL to support a wider range of clinical trials and diagnostic work, and it provides strong momentum to accredit additional assays that we can eventually transition into the NHS setting.”
