A groundbreaking test designed to predict whether breast cancer may return after treatment is being introduced in Britain.
In trials, it identified women whose disease later came back as far as 15 years after their initial diagnosis.
Known as Caris MI Clarity, the test could help doctors determine which patients require closer follow-up or further treatment, potentially improving survival.
Developers say it costs £769, provides results within three days and could be suitable for as many as 20,000 women in Britain each year.
The test will be offered to NHS oncologists and leading private healthcare providers this month. However, patients will initially need to cover the cost themselves or use private medical insurance.
Cancer charities told the Daily Mail that, if the technology performs as expected, it could make an important contribution to the vital effort to prevent recurrence.
Caris MI Clarity is intended for postmenopausal women with early-stage hormone receptor-positive, HER2-negative breast cancer that has not spread to the nearby lymph nodes.
Although this form of breast cancer can often be treated successfully, some patients remain at risk of a delayed recurrence—even after going more than 10 years without evidence of disease.
A new test being introduced in Britain aims to predict the long-term risk of breast cancer returning after treatment.
When breast cancer returns, it can spread to organs such as the bones, liver and lungs. This distant recurrence accounts for the overwhelming majority of deaths from the disease.
More than 11,000 people die from breast cancer in Britain each year.
Doctors have traditionally found it difficult to identify which patients face the greatest risk of recurrence, particularly when the disease may return many years after treatment.
Current tests analyse gene activity inside a tumour to estimate that risk, but patients may have to wait several weeks for the results.
According to its developers, Caris MI Clarity uses a different method.
The artificial intelligence-based system analyses digital images of a patient’s tumour captured at the time of diagnosis, together with other clinical information.
It searches for features and patterns associated with tumours that later returned.
The assessment then generates two separate risk scores.
One score estimates the chance of recurrence within five years of diagnosis, while the other assesses the likelihood of the cancer returning between five and 15 years later.
Doctors can use the results alongside other clinical information when considering additional treatment or deciding how closely a patient should be monitored in the future.
The technology was developed using data from thousands of women who participated in two large international breast cancer studies.
Researchers tracked the patients over time and compared the characteristics of tumours that came back with those that did not.
That work allowed them to create a system aimed at recognising warning signs linked to later recurrence.
‘Breast cancer returning many years after the original diagnosis is one of the major challenges we still need to tackle,’ Dr Kotryna Temcinaite, senior research and impact communications lead at Breast Cancer Now, told the Mail.
‘It is vital that we improve our understanding of who is most likely to experience a recurrence, whether that happens in the first few years after diagnosis or much further down the line, so patients can receive the most effective treatment.’
The charity said it would be watching closely to see how the test performs in real-world clinical settings.
‘Understanding why some breast cancers return—and finding ways to prevent that—is a leading research priority for us,’ Dr Temcinaite added. ‘People should not have to live with an all-consuming fear of recurrence; everyone diagnosed with breast cancer deserves the chance to live well.’
The test is already available in the United States and is now being introduced in Britain by Cambridge-based diagnostics firm EDX Medical, founded by scientist and entrepreneur Professor Sir Chris Evans.
‘Bringing this genuinely pioneering test to the UK gives breast cancer patients and their doctors access to valuable insight into both the short- and long-term risk of recurrence,’ Prof Sir Evans said.
‘It represents a significant advance in risk assessment and treatment planning for these patients.’
About 60,000 women are diagnosed with breast cancer in Britain each year.
Roughly three quarters of those cases are hormone receptor-positive, HER2-negative breast cancer, although the new test will not be appropriate for every patient in that group.
After considering age and other eligibility requirements, the developers estimate that up to 20,000 women annually could benefit from the test.
Despite being available to NHS oncologists, however, Caris MI Clarity will not initially be paid for by the health service.
The Mail understands that there are currently no immediate plans to provide the test free of charge to NHS patients.
George Sledge, chief medical officer at Caris Life Sciences, which is partnering with EDX Medical to bring the technology to Britain, said: ‘For years, breast cancer specialists have had to make some of their most important treatment decisions without a complete understanding of how a patient’s recurrence risk changes over time.’
