Why bioinformatics helps medical laboratories

Medical laboratories handle high volumes of samples under tight timelines, consistently delivering reliable results.

As essential components of the healthcare system, they support both diagnostics and public health. Accreditation ensures the quality and reproducibility of their outputs.

Medical laboratory services range from patient-focused diagnostic testing to the analysis of surveillance samples for public health. The data produced flows through healthcare systems to inform patient care, hospital outbreak responses, and broader decisions at regional or national levels, including policy-making and pandemic response.

The reliability of medical laboratory outputs is critical. Ensuring laboratories are competent to perform tests and produce accurate data is essential. In a globally connected healthcare landscape, results from one laboratory should be comparable to those from another. This requires systems that support collaboration across laboratories and healthcare services, both nationally and internationally. ISO accreditation enables this.

Using genomics in medical laboratories

The widespread adoption of genomics and high‑throughput sequencing has transformed laboratory practice. Increasingly, reported results rely on digital processes such as bioinformatics pipelines, software tools, and data interpretation steps that occur downstream of the wet lab. Despite their critical role in determining result validity, these activities are often poorly defined within existing accreditation frameworks.

This gap presents a challenge for laboratories seeking to deliver genomics services that are both innovative and accredited. It also has significant implications for low- and middle-income countries, where the absence of clear, globally accepted best practice risks widening existing inequities.

The project has identified a set of simple, foundational measures to support the accreditation of bioinformatics activities within ISO 15189 and ISO 17025 laboratories. These measures improve quality, enable service development, and provide guidance for researchers and funders to support clinical translation.

By focusing on key pinch points, this project will work to lower barriers to genomics adoption and strengthen global preparedness for future health threats.