EDX Medical Group plc (AIM: EDX), the Cambridge-based digital diagnostics company, has announced the UK launch of Caris MI Clarity, described as the first prognostic test capable of assessing both short and long-term breast cancer recurrence risk in a single assessment at the time of initial diagnosis. The AI-powered test, developed in partnership with US precision medicine company Caris Life Sciences, provides risk stratification extending up to 15 years. The launch expands EDX Medical's portfolio of advanced diagnostic tools targeting clinicians, hospitals, and insurers across the UK.

Key Points

  • EDX Medical Group plc (AIM: EDX), headquartered in Cambridge, UK
  • UK launch of Caris MI Clarity, the first single test assessing both early (0–5 years) and late (5–15 years) breast cancer recurrence risk at diagnosis
  • Test validated by clinical data from tens of thousands of participants; targets postmenopausal patients with HR-positive/HER2-negative, node-negative early-stage breast cancer
  • Investors will be watching for commercial uptake metrics and further partnership announcements as EDX Medical builds out its diagnostic product portfolio

Caris MI Clarity Addresses a Gap in Early-Stage Breast Cancer Risk Assessment

The Caris MI Clarity test targets postmenopausal patients with HR-positive, HER2-negative, node-negative early-stage breast cancer — a population for whom accurate recurrence risk assessment is considered central to treatment planning. The announcement states that clinicians currently evaluate early and late distant recurrence risk separately using existing tools, adding complexity to their decision-making. Caris MI Clarity integrates image, clinical, and molecular data through a multimodal AI model to deliver a single, combined risk assessment at the point of initial diagnosis, stratifying patients into low- or high-risk categories across both timeframes.

EDX Medical Partners with Caris Life Sciences to Supply the Test Across the UK

EDX Medical has entered into a supply agreement with Caris Life Sciences, a US-headquartered AI TechBio and precision medicine company, to distribute the test within the United Kingdom. The company did not disclose the financial terms of this agreement in the announcement. This partnership adds to EDX Medical's existing strategic relationships, which include Thermo Fisher EMEA Ltd. The agreement positions EDX Medical as the UK conduit for a test that has been validated through large-scale clinical trials, though the company did not specify a commercial launch timeline or volume targets in the announcement.

AI and Multimodal Data Integration Underpin the MI Clarity Testing Model

The Caris MI Clarity test leverages artificial intelligence applied to tumour pathology samples combined with clinical data, enabling what the announcement describes as a transformative approach to understanding recurrence risk over time. The test has been validated using data from tens of thousands of participants across clinical trials. For EDX Medical, whose business model centres on translating clinical insights into digital diagnostic solutions, the product aligns directly with its stated focus on early disease detection and personalised treatment optimisation — areas the company considers central to improving patient outcomes and reducing healthcare costs globally.

Professor Sir Chris Evans and Dr Mike Hudson Highlight Clinical Significance of UK Availability

Founder and Chief Scientific Officer Professor Sir Chris Evans stated the test offers patients and clinicians "invaluable insight" into both short and long-term recurrence risk. Chief Executive Dr Mike Hudson described MI Clarity as fitting "superbly" into EDX Medical's portfolio of advanced diagnostic tests. George W. Sledge, Chief Medical Officer at Caris Life Sciences, noted that breast cancer clinicians have historically faced consequential treatment decisions without a complete picture of how recurrence risk changes over time. The company did not disclose pricing, reimbursement arrangements, or specific NHS commissioning details in the announcement.