Artera has won FDA clearance for ArteraAI Breast, its breast cancer platform for patients with early-stage HR-positive, HER2-negative invasive breast cancer.

ArteraAI Breast is the first and only FDA-cleared digital pathology-based risk stratification tool for breast cancer.

These FDA milestones come alongside recent CE marking for both the ArteraAI Prostate Biopsy Assay and the ArteraAI Breast Cancer Assay in the US and Europe.

“FDA clearance for ArteraAI Breast represents a significant expansion of our FDA-cleared AI platform in oncology,” said Andre Esteva, chief executive and co-founder of Artera.

“This milestone reflects the growing role of our technology across multiple cancer types. Breast cancer care is highly nuanced, with treatment decisions that depend on individualised risk.

“Our goal remains consistent across prostate and breast cancer, and beyond: to help clinicians translate complex data into more precise, personalised treatment decisions across the cancer journey.”

ArteraAI Breast generates an AI-derived risk score showing the likelihood of distant metastasis, meaning cancer spreading to another part of the body, in patients with early-stage HR-positive, HER2-negative breast cancer.

Using digitised histopathology images, which are scanned tissue sample images, alongside patient clinical variables, the model sorts patients into low-risk and high-risk groups based on a predefined risk score cut-off.

In early-stage HR-positive, HER2-negative breast cancer, deciding the right intensity of treatment can be complex because clinical and pathological factors vary. Artera said the tool is designed to support clinicians within established decision-making frameworks.

Data presented at the 2025 San Antonio Breast Cancer Symposium evaluated the model in early-stage breast cancer and demonstrated the potential to inform chemotherapy benefit in certain patient populations.

“This clearance represents an important advance on the road to personalising treatments for patients with early-stage breast cancer,” said Eric Winer, medical oncologist and director of the Yale Cancer Center.

“Using AI and digital pathology has the potential to streamline operational workflows, while creating a strong interdisciplinary linkage between oncology and pathology. This approach may further improve the clinicians’ ability to help patients make the best treatment decisions.”

ArteraAI Breast is designed to integrate directly into standard pathology workflows using routine surgical resection samples, without requiring additional tissue or separate specimen collection.

This approach allows the software to provide same-day results, enabling pathology laboratories to give clinicians patient-specific prognostic risk information alongside standard histopathology reports.

A nurse who works with breast cancer patients has spoken of her pride after joining a trial that improved breast cancer surgery after her own diagnosis.

Heidi Jones, a 53-year-old staff nurse on the surgical day unit at Basildon Hospital, is a mother of two from Corringham in Essex and works with breast cancer patients daily.

She was diagnosed with breast cancer in 2025, the day after her birthday. She told ITV News Anglia that she had jumped at the opportunity to take part in the trial.

“I said yes because we need to get out there about the advancements in treatment and in surgery and medicines,” she said.

“Cancer is a big thing, so whatever you can do to improve the treatment of the cancer, I was all for it.”

Mid and South Essex NHS Foundation Trust was one of two UK centres taking part in the trial, alongside 21 others across the US, Canada and Austria.

The trial involved using a breast cancer locator, or BCL, a customised 3D mould matched to the unique dimensions of the patient’s tumour and breast.

The BCL is then placed over the patient during surgery, giving teams more detailed guidance on the tumour’s shape, size and location.

Results found a 34 per cent reduction in the number of second surgeries needed, and a 32 per cent reduction in cases where cancer remained after surgery.

Surgeon Wayne Chicken said the new technique could have a big impact on some patients.

“I’ve been working in breast surgery for 25 years, and breast surgery has changed radically in those 25 years,” he said.

“Now we’re trying to do less and less, the minimum necessary to control the disease, rather than big procedures and potentially over-treat cancers. This is doing the minimum necessary to treat the cancer.”

This actually uses the information from the MRI scans to plan, so the impact is less surgery and more likely to get it right in a single operation.

Using the BCL system, Jones’s breast cancer surgery was a success, with the tumour removed completely.

“I do talk about things quite openly, and I use it now when the ladies are coming in. I’ll tell them I’ve gone through it,” she said.

“It just gives them that little bit more to let them know someone else has come through [treatment] and has come through the other side.

“I feel proud that I actually took part in it. I feel privileged to have taken part in it and been asked to do it.

“I’m extremely glad it’s been really successful as well. I was lucky, I class myself lucky.”

Obesity may be a key driver of rising rates of 11 cancers in adults under 50, a study has found.

The 11 cancers were thyroid, multiple myeloma, liver, kidney, gallbladder, colorectal, pancreatic, endometrial, oral, breast and ovarian cancers.

All except oral cancer are known to be linked to excess weight, with researchers saying raised insulin levels and inflammation may play a part.

The findings come from researchers at the Institute of Cancer Research, London and Imperial College London, who analysed national cancer registry data for England from 2001 to 2019.

In England, around 31,000 cancers were diagnosed in people aged 20 to 49 in 2023, equal to roughly one in every 1,000 people. This compares with 244,000 cases in the 50 to 79 age group, where the rate is around one in 100.

Concerns have been growing in recent years over rising rates of cancers such as bowel and ovarian in younger adults.

Among the younger group, breast cancer was the most common, with 8,500 cases, followed by bowel cancer at 3,000 and melanoma skin cancer with 2,800 diagnoses.

For nine of the 11 cancers identified, rates are rising in younger adults but also increasing in older adults, who are much more likely to develop the disease. Bowel and ovarian cancer were the exceptions, rising only in younger age groups.

The researchers found that bowel cancer rates in younger women linked to BMI rose faster, from 0.9 to 1.6 per 100,000 people, than those not linked to BMI, which rose from 6.4 to 9.6 per 100,000 people. Similar patterns were recorded for men.

However, the authors noted that the overall number of cases of BMI-linked bowel cancer in younger women remained lower than those not linked to BMI, suggesting other factors must be contributing to the increase.

Several suspected contributors, including ultra-processed foods, antibiotic use and air pollution, have been proposed in recent years. However, many of these factors have also shown stable or declining trends in the UK, the team said.

Despite the rise in several cancer rates among younger adults over the past two decades, most established risk factors, including smoking, alcohol consumption, red or processed meat intake, low fibre diets and lack of exercise, remained stable or even declined in the period leading up to diagnosis.

This suggests these traditional risk factors are unlikely to account for much of the increase in cancer cases.

By contrast, overweight and obesity, which have increased steadily since 1995, could be key factors in the rise in cases. The team suggested that between 2001 and 2019, around 20 per cent of the increase in bowel cancer was explained by increases in BMI over that period.

However, the researchers said rises in BMI alone are not enough to explain the overall increase in cancer among younger adults in England and that there are likely to be other causes.

Data also suggest around 15 per cent of bowel cancer in younger people could be linked to being overweight or obese, with around 40 to 50 per cent in total linked to the combined effect of known risk factors such as obesity, lack of exercise, alcohol and smoking.

Montse García-Closas, professor at the ICR, said more research was needed, but “we cannot wait to act”.

She told a media briefing: “Our main conclusion is that although BMI is our best clue, much of the increase still remains unexplained, and we’ve done some additional analysis that show that most likely what’s missing is not just a single cause unexplained, but it’s likely a combination of multiple factors that act together.”

Amy Berrington, professor at the ICR, said: “Although rates have been increasing, cancer in young people is still a rare disease.”

Marc Gunter, professor at Imperial, said obesity was a known risk factor for around 19 different cancers.

He added: “For some of these cancers, including colorectal (bowel) cancer, we think this could be partly caused by higher levels of hormones such as insulin, which is often elevated in people with obesity, as well as inflammation.

“We know people with obesity have higher levels of insulin, and insulin is a growth factor and has been linked to cancer.

“In a recent study, we actually found that insulin in particular might be playing a role in early onset colorectal (bowel) cancer, and this is actually an area of very active research at the moment.”

The researchers called for large, long-term studies to identify all the biological and environmental factors that could explain rising cancer rates in young adults.

García-Closas added: “Tackling obesity across all ages, particularly in children and young people, through stronger public health policies and wider access to effective interventions, could slow the rise in cancer and prevent many cancers and must become a national priority.”

Michelle Mitchell, Cancer Research UK’s chief executive, said: “Globally, and in the UK, we’re seeing a small increase in cancer rates in adults under 50.

“The picture is complex and we need more research to understand what’s driving the trend, but this study helps to fill in some gaps.

“Overweight and obesity doesn’t explain the rise in full though. Improvements in detection are likely to also be playing a part, meaning that more people are being diagnosed at a younger age.

“Preventing cancer cases must be a priority for the UK government. Smoking remains a leading cause of cancer in adults under 50, which is why the Tobacco and Vapes Bill receiving royal assent this week is such a historic moment.

“Measures to restrict the advertising and promotion of junk food, introducing mandatory reporting and targets on healthy food sales, and making nutritious food more accessible to everyone would all help people keep a healthy weight.”