Diagnosis
Women pay for AI to boost mammogram findings
More than a third of women across 10 health care practices in the US chose to enrol in a self-pay, artificial intelligence (AI)-enhanced breast cancer screening programme, and the women who enrolled were 21 per cent more likely to have cancer detected, according to new research.
AI has shown great promise in mammography as a “second set of eyes” for radiologists providing decision support, risk prediction and other benefits.
Despite its promise, AI is not yet reimbursed by insurance in the United States, which likely is slowing its adoption in the clinic. Some practices have elected to offer enhanced workflows enabled by AI at additional cost, much like what was done when digital breast tomosynthesis was originally deployed.
For the study, researchers investigated the impact of AI—including a safeguard review—as a self-pay option in screening mammography.
A self-pay, AI-powered screening mammography program was offered to patients across 10 clinical practices, ranging from a few sites up to 64 sites at the largest practice. Women who enrolled had U.S. Food and Drug Administration-compliant AI software applied to their mammograms.
An expert breast radiologist provided a third, safeguard review in cases where there was discordance between the first reviewer and the AI.
Out of the 747,604 women who underwent screening mammography over an initial 12-month period, the overall cancer detection rate was on average 43 per cent higher for enrolled women than for unenrolled women. The pattern of a substantially higher cancer detection rate in enrolled women was observed at all 10 practices.
Further analysis attributed 21 per cent of the increase in cancer detection to the AI programme. The researchers credited the remaining 22 per cent increase in detection to the fact that higher-risk patients chose to enrol more frequently.
“These data indicate that many women are eager to utilise AI to enhance their screening mammogram, and when AI is coupled with a safeguard review, more cancers are found,” said study senior author Gregory Sorensen, from DeepHealth.
The recall rate—the rate at which women were called back for additional imaging—was 21 per cent higher for enrolled versus unenrolled women. Relatedly, the positive predictive value for cancer was 15 per cent higher for the enrolled women, indicating that each recall resulted in more cancer diagnoses in the enrolled population.
“This is the first report on results from a program that provides an AI-powered enhanced review that patients can elect to enrol in,” said study lead author Bryan Haslam, from DeepHealth.
“The AI-driven enhanced review programme leverages AI in a novel workflow to ensure women with suspicious findings get expert level care that could help detect many more breast cancers early.
“The number of women electing for this program is now at 36 per cent and growing, and the rate of cancer detection continues to be substantially higher for those women.”
In the future, the researchers hope to better quantify the benefit of the AI-driven safeguard review with prospective randomised controlled trials that would eliminate the self-selection bias and provide the highest level of evidence.
Menopause is often absent from women’s electronic health records, a study of nearly 396,000 women has found.
Researchers found menopause appeared almost seven times more often in participant surveys than in electronic health records (EHRs).
The findings suggest important reproductive health information, including age at menopause, may often be missing from health records used for research.
Audrey Hendricks, associate professor of bioinformatics at CU Anschutz and the study’s principal investigator, said: “Ultimately, we cannot study what we do not measure. We cannot treat what we do not know.
“Menopause has enormous implications for women’s health, but if we don’t consistently capture when menopause occurs and other important reproductive health information, we limit our ability to understand how this transition affects disease risk and health outcomes.”
Researchers at the University of Colorado Anschutz analysed data from women taking part in the National Institutes of Health’s All of Us Research Program.
They compared menopause information reported by participants in surveys with menopause diagnoses recorded in their electronic health records.
Around 193,000 menopause observations were identified in survey data, compared with approximately 28,000 diagnoses in EHR data.
Menopause was documented in electronic health records for only about 7 per cent of women in the dataset.
Nearly all participants with a menopause diagnosis recorded in their EHR also reported menopause in survey data. However, substantially fewer women had menopause documented in their health records.
Other important information was also frequently unavailable, including age at menopause, which researchers may use when examining links between menopause and chronic disease risk.
Menopause is a physiological transition that can affect cardiometabolic health and many other aspects of women’s health.
Researchers said relatively little is known about how factors including the timing and type of menopause influence health outcomes across diverse populations.
Large-scale programmes such as All of Us combine participant surveys, electronic health records and genomic data, but menopause-related research depends on relevant reproductive health information being available.
Missing menopause information can make it harder to investigate how the transition relates to health and disease.
The findings may also help researchers using All of Us data define menopause-related study populations, design studies and estimate how many participants are needed.
Hendricks said: “We have an enormous opportunity to use large-scale datasets to understand women’s health across the menopause transition and to identify who may be at greater risk for disease.
“But we need to make sure that the information researchers need is actually being collected.
“We must do a better job of capturing women’s health information, including reproductive health and measures related to menopause.”
Researchers said more complete and consistent collection of menopause and reproductive health information could help future studies examine factors such as age at menopause and their relationship with disease risk and health outcomes.
The FDA has granted accelerated approval to AstraZeneca drug Etcamah for certain adults with advanced breast cancer carrying an ESR1 mutation.
Etcamah, also known as camizestrant, was approved in combination with a CDK4/6 inhibitor, either abemaciclib, palbociclib or ribociclib.
The treatment is for adults with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer when an estrogen receptor-1 (ESR1) mutation is detected during aromatase inhibitor and CDK4/6 inhibitor therapy using an FDA-authorised test.
ESR1 mutations are acquired resistance mutations that tumours may develop during treatment with aromatase inhibitors, a type of endocrine therapy commonly used as a front-line treatment for locally advanced or metastatic breast cancer.
Fewer than 5 per cent of patients have the mutation when HR-positive metastatic breast cancer is diagnosed, according to the FDA. After disease progression on an aromatase inhibitor, nearly 40 per cent have the mutation.
Acting FDA commissioner Kyle Diamantas said: “Women living with metastatic breast cancer face an uphill battle as their tumors continuously evolve to escape treatment.
“We owe them every weapon in our arsenal.
“Today’s approval delivers a win to these patients by granting them a targeted therapy designed specifically to overcome resistance, giving them more time before their disease progresses.”
The accelerated approval programme allows earlier approval of drugs that treat serious conditions and fill an unmet medical need based on surrogate or intermediate endpoints.
For Etcamah, approval was based on how long patients lived without their disease worsening, measured from when the resistance mutation was first detected in their blood.
The FDA said it has not yet been confirmed whether intervening when the mutation is detected, rather than waiting until disease progression is confirmed, results in a clinically meaningful benefit. Confirmatory studies are therefore required to verify and describe clinical benefit.
Angelo de Claro, director of the FDA’s Oncology Center of Excellence, said: “I commend both the FDA and the sponsor for their commitment to advancing cancer care and securing this accelerated approval.
“This marks the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) before imaging tests show that the disease is progressing.
“But additional evidence is needed to confirm clinical benefit.”
Circulating tumour DNA, or ctDNA, consists of small pieces of tumour DNA released into the blood and can allow earlier molecular detection of resistance mutations.
The FDA also authorised the Guardant360 CDx assay as a companion diagnostic to identify patients with breast cancer who have ESR1 mutations for treatment with camizestrant.
Efficacy was assessed in a clinical trial comparing a switch to Etcamah plus a CDK4/6 inhibitor with continued treatment using an aromatase inhibitor plus a CDK4/6 inhibitor.
Estimated median progression-free survival was 16 months in the Etcamah group, compared with 9.2 months in the aromatase inhibitor group.
Etcamah’s prescribing information includes a boxed warning about the risk of irregular heart rhythm when taken with certain other medicines. It also includes warnings about an abnormally slow heart rate and potential harm to an unborn baby.
The FDA convened its Oncologic Drugs Advisory Committee for the application on 30 April 2026.
Four leading cardiovascular health groups have agreed new guidance for healthcare professionals assessing patients with suspected heart attacks.
Historically, some less common forms of heart attack, which evidence shows affect women far more than men, have been classified as less important, with treatment and care often worse as a result.
Experts said women had been receiving less effective treatments that did not always target the specific cause of their heart attack and could even make them more unwell.
The changes were announced in Munich on the opening day of the annual congress of the European Society of Cardiology (ESC).
Professor Bryan Williams, chief scientific and medical officer of the British Heart Foundation, said: “This is a landmark moment, a radical shift in how we define and diagnose heart attacks worldwide which will transform people’s care.
“For decades, women have missed out on accurate diagnoses and treatment.
“This focus on finding less common causes of heart attacks, which predominantly affect women, should help to change that. It could be life-changing for huge numbers of women in the UK and worldwide.”
The new guidance upgrades three types of heart attack that can be up to 10 times more common in women and are often caused by childbirth, exercise and emotional stress.
The most serious cases, previously known as “type 1” and now classed as “primary” heart attacks, had previously prioritised those caused by a clot blocking blood flow to the heart.
Other forms can involve reduced blood flow for different reasons, including the tightening or tearing of coronary arteries. These can be more likely to be missed or treated less urgently.
The guidance also introduces a lower diagnostic threshold for women based on levels of troponin, a protein released into the blood when the heart is injured and damaged.
Previously, women were expected to meet the same troponin threshold as men to receive a diagnosis.
Williams said the streamlined heart attack categories would also help patients understand the cause of their heart attack and what comes next.
The three upgraded types are coronary artery spasm, coronary embolism and spontaneous coronary artery dissection (SCAD).
Coronary artery spasm involves the tightening of an artery, which can deprive the heart muscle of blood and oxygen. It can be caused by emotional stress, exercise or extreme cold.
Coronary embolism occurs when a blood clot or fatty deposit travels to a coronary artery and causes a blockage.
SCAD is caused by a tear in a coronary artery. Around 80 per cent of cases occur in women, and it often happens during or soon after pregnancy.
Professor Nicholas Mills, a cardiologist at the University of Edinburgh who led the international taskforce behind the guidance, said it was “the first time that we’ve had a truly global approach to aligning how we diagnose what is probably the most important diagnosis there is”.
He said: “It kills so many people, and we’ve never got everyone together around the world to agree how we’re going to describe it, classify it, explain it to our patients.
“Our job now is to implement this as widely as possible. It’s just as relevant for the UK as it is for any other country around the world. It is a revolution. It’s going to make care better for patients.”
Mills said there had been “unintended systematic bias against women”, including through the use of the key blood test for diagnosing heart attacks at an average level, which picks up all men but misses some women.
He said: “This is used for all types of heart attack in every emergency department in the world, and we want to make sure that it’s used correctly.”
The guidance was drawn up by the ESC, the American College of Cardiology, the American Heart Association and the World Heart Federation.
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