NEWS The whole picture…
Welcome to another issue of Pathology in Practice, one in which the breadth of content goes some way to illustrating the diverse challenges and opportunities across laboratory medicine in 2026. Over the next 50-odd pages we’re covering laboratory statistics, EQA data, virology and influenza vaccine planning, advances in point- of-care testing, education and training, digital pathology benefits, as well as an introduction to value-based procurement for NHS pathology services. My thanks to our valuable contributors;
we quite literally couldn’t do it with you. The collegiate and supportive atmosphere within this branch of healthcare continues to impress me as I near the start of my fifth year with PiP. If you’d like to join them, please do get in touch! A regular contributor over the past few years is Stephen MacDonald of Cambridge University Hospitals NHS Trust. I’m pleased to say this issue sees him starting a new series of articles looking at data; beginning with an introduction to statistical interpretation focusing on improving the
The collegiate and supportive atmosphere continues to impress
quality of the first statistical encounter with a dataset. To complement the article Stephen has also developed a teaching tool for basic understanding of probability distributions, which can be found online – alongside a wealth of other material on measurement uncertainty and associated areas. Also covering the data aspect are Ceri Parfit and Annete Thomas of Weqas, who look at different models for determining analytical performance specifications (APS). Their article looks at historical data to discover what is achievable in a real-world environment, to aid in seting clinically appropriate APS for several serum chemistry analytes. Maria Zambon of UKHSA takes us though the biannual process of formulating influenza vaccines. With timing a crucial aspect of the
SAGA acquisition boosts Roche diagnostics
Roche has completed a deal to acquire SAGA Diagnostics worth almost $600 million, adding the firm’s Pathlight platform to its diagnostics portfolio. As a result of the acquisition, Foundation Medicine – an independent affiliate of Roche – is set to expand its monitoring portfolio with SAGA Diagnostics’ tumour- informed molecular residual disease (MRD) platform. Roche will pay a total of up to $595 million, inclusive of commercial and regulatory milestone payments. The transaction is subject to customary closing conditions including regulatory approvals, and is expected to close in Q3 2026, at the latest. Following the closing of the transaction, the Pathlight platform will be fully integrated into Foundation Medicine. Pathlight’s MRD platform will strengthen
Foundation Medicine’s portfolio of high- quality diagnostic tests and solutions that support treatment selection, and the monitoring of both treatment response and
disease recurrence. Foundation Medicine also plans to leverage Roche’s AXELIOS sequencing platform and the Digital LightCycler PCR platform to develop a decentralised MRD solution which will enable patient access in healthcare setings worldwide. Pathlight uses a proprietary
combination of whole genome sequencing (WGS) and digital PCR to identify and track large-scale genomic changes
known as structural variants (SVs). By optimising for SVs, Pathlight enables ultra-sensitive MRD detection. Pathlight is covered by Medicare for cancer recurrence monitoring in early-stage breast cancer across all subtypes. It is currently available for patients within the United States, with plans for international launch. “Pathlight strengthens our
comprehensive portfolio of diagnostic solutions and reinforces our commitment to transforming cancer care throughout a patient’s experience,” said Dan Malarek, CEO of Foundation Medicine.
From the Editor
vaccine campaigns, she explains the work done by UKHSA, the WHO and others in coordinating an international effort and how it can be impacted by new virus strains making an unwelcome appearance. From a business perspective, Beth
Loudon of BIVDA introduces value-based procurement in the NHS. One thing the NHS certainly isn’t short of currently is change; but the move to value-based procurement – and away from a focus on costs and specifications and towards patient-centred benefits – should be a positive move. As Beth explains though, when looking at pathology services and diagnostic tests, quantifying these benefits presents some difficulties. As the digital pathology arms race
continues, with ever more features, AI input and increasing potential, Signify Research has taken the step of speaking to pathologists to see what is actually required of the new technology. The results make for interesting reading. Enjoy the issue!
Andy Myall
andymyall@pathologyinpractice.com
MHRA expands AI Airlock
The Medicines and Healthcare products Regulatory Agency (MHRA) has secured a major funding uplift to expand its pioneering AI Airlock programme, the UK’s first regulatory sandbox for Artificial Intelligence as a Medical Device (AIaMD). Following a successful second phase, the Department of Health and Social Care (DHSC) has allocated £1.2 million per year for the next three years (2026–2029) to the programme. The newly approved multi-year funding will enable the AI Airlock programme to scale beyond the constraints of yearly financial cycles. This will support more ambitious, longer-term testing models while helping to create a more sustainable regulatory pathway for future AI medical technologies. AI Airlock is led by the MHRA in
partnership with DHSC, NHS AI Team, and Team AB (the consortium of UK Approved Bodies). The project has continued to grow since the launch and early pilot phase in 2024, with a second round of projects opening in 2025. Reporting for phase two is expected to be published in Summer 2026.
May 2026
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