EDX Medical partners with Caris to launch AI breast cancer test in the UK

EDX Medical is launching an AI breast cancer test in the UK to assess the risk of recurrence for up to 15 years after diagnosis.

The Caris MI Clarity test is designed for postmenopausal patients with hormone receptor-positive (HR-positive), HER2-negative, node-negative early-stage breast cancer.

HR-positive cancers are influenced by hormones, while HER2-negative cancers do not have elevated levels of the HER2 protein. Node-negative means the cancer has not spread to nearby lymph nodes.

The test assesses both short- and long-term recurrence risk, potentially helping clinicians make treatment decisions at the time of diagnosis.

EDX Medical has signed an agreement with US-based Caris Life Sciences to supply the test in the UK.

The company describes MI Clarity as the first prognostic test to assess early and late breast cancer recurrence risk in a single assessment.

A prognostic test estimates how a disease may develop, including the likelihood of it returning after treatment.

MI Clarity uses artificial intelligence to analyse tumour tissue images alongside clinical and molecular data.

It places patients into low- or high-risk categories for distant recurrence, when cancer returns in another part of the body, during two periods: the first five years after diagnosis and between five and 15 years.

According to EDX Medical, the test has been validated using clinical data from tens of thousands of participants in clinical trials.

Existing tests frequently assess early and late distant recurrence risk separately, adding complexity to treatment planning.

MI Clarity combines both assessments to help clinicians understand how a patient’s risk may change over time.

Professor Sir Chris Evans, founder and chief scientific officer of EDX Medical, said: “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 of EDX Medical, said: “MI Clarity fits superbly into our portfolio of advanced diagnostic tests, which provide doctors and their patients the most accurate digital diagnostic tools to inform treatment decisions.”

George W. Sledge, chief medical officer at Caris Life Sciences, said clinicians often had incomplete information about how recurrence risk changes over time.

“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.”

He added: “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 personalise care for postmenopausal patients with HR-positive/HER2-negative, node-negative breast cancer.”

The test will be available in the UK through EDX Medical’s diagnostic portfolio under its agreement with Caris Life Sciences.

The companies say the longer-term risk assessment could support more personalised treatment planning.