A new test that assesses the risk of breast cancer recurrence for up to 15 years is being launched in the UK.
It is the first of its kind in that it is a single test that leverages AI to assess risk of recurrence both short and long-term. It could benefit up to 20,000 postmenopausal women in the UK per year and provides results with three days, rather weeks which is the current norm.
The clinical test, which targets postmenopausal patients with HR-positive/HER2-negative, node-negative early-stage breast cancer, was launched in the US earlier this year and is being brought to the UK by EDX Medical, a Cambridge-based diagnostics company specialising in the early detection of major diseases.
EDX Medical has entered into an agreement with Caris Life Sciences, a leading US-based next-generation AI TechBio and precision medicine company, to provide the Caris MI Clarity test in the UK.
The test utilises AI to transform how the risk of breast cancer recurrence is understood for postmenopausal patients with HR-positive/HER2-negative, node-negative early-stage breast cancer, and has been validated by robust clinical data from tens of thousands of participants in clinical trials1 &2. The test is applied at the time of initial diagnosis.
The test replaces the need for two tests that take can take several weeks. Its appeal is enhanced by its speed, convenience and covering both early and late recurrence risk in one report.
Professor Sir Chris Evans, founder and chief scientific officer of EDX Medical, commented: “Bringing this truly pioneering test to the UK offers breast cancer patients and their doctors the opportunity to gain invaluable insight into the risk, both short and long term, of disease recurring. This test is a very significant step forward in terms of risk assessment and treatment planning for those patients.”
Dr Mike Hudson, chief executive, EDX Medical, commented: “MI Clarity provides doctors and their patients the most accurate digital diagnostic tools to inform treatment decisions.”
“Breast cancer clinicians have long been forced to make some of the most consequential treatment decisions with an incomplete picture of how recurrence risk changes over time,” said George W. Sledge, Chief Medical Officer at Caris. “Caris MI Clarity is designed to bring early and late distant recurrence risk together in a single test at the time of initial diagnosis, when treatment decisions matter most. By leveraging AI on tumour pathology sample combined with clinical data, Caris MI Clarity has the potential to fundamentally improve how we personalize care for postmenopausal patients with HR-positive/HER2-negative, node-negative breast cancer.”
For patients with early-stage breast cancer, accurately assessing the risk of distant recurrence is essential, as distant recurrence is the primary driver of mortality and is considered to be a key factor in treatment decisions.
Using tests currently available, clinicians frequently evaluate early and late distant recurrence risk separately, adding complexity to treatment planning. The Caris MI Clarity test is based on a multimodal Artificial Intelligence (AI) model integrating image, clinical and molecular data to assess both short and long-term risk at the time of diagnosis.
The test provides distinct risk stratification into low- or high-risk categories for both early (0–5 years) and late (5–15 years) distant recurrence, enabling clinicians to understand how recurrence risk may unfold over time.
