Diagnosis
FDA fast tracks BRCA breast cancer drug
The US Food and Drug Administration (FDA) has granted fast track status to a new drug combination for BRCA-mutated advanced breast cancer.
The designation covers ART6043, developed by Artios, used with the PARP inhibitor Lynparza, also known as olaparib.
It applies to adults with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer who have not previously been treated with a PARP inhibitor.
BRCA mutations are inherited genetic changes that increase the risk of breast cancer.
PARP inhibitors block cancer cells from repairing damaged DNA, but tumours with BRCA mutations often develop resistance when these drugs are used alone.
ART6043 is designed to address this resistance. The oral treatment inhibits DNA polymerase theta, or Polθ, an enzyme found in cancer cells but largely absent in healthy tissue.
By blocking Polθ, the drug targets a backup DNA repair process known as microhomology-mediated end joining, which cancer cells rely on when other repair pathways are disrupted.
The aim is to limit the tumour’s ability to repair itself and extend the effectiveness of PARP inhibitors.
The fast track decision was supported by data from an ongoing first-in-human phase 1/2a trial evaluating ART6043 in combination with Lynparza in patients with advanced solid tumours carrying mutations in DNA damage response pathways, including BRCA-mutated breast cancer.
Findings presented at the European Society for Medical Oncology Congress 2025 showed what the company described as expected pharmacokinetic and pharmacodynamic activity, as well as encouraging clinical signals.
Breast cancer is the second leading cause of cancer death among women in the US. Patients with BRCA mutations who develop resistance to PARP inhibitors often have limited treatment options.
The FDA fast track programme is intended to speed up the development and review of investigational medicines that may address serious or life-threatening conditions with unmet medical need.
The designation allows Artios to engage more frequently and earlier with the FDA to discuss the development pathway for ART6043.
Under the programme, the drug candidate may be eligible for priority review and accelerated approval if it meets the relevant clinical criteria.
HER2-negative breast cancer does not overproduce the HER2 protein, which drives tumour growth in some patients.
Locally advanced cancer has spread to nearby tissue but not distant parts of the body, while metastatic cancer has spread to other organs.
AI could help routine mammograms spot heart disease risk in women, as well as breast cancer, researchers have found.
A team from Emory University analysed regular screening scans from more than 123,000 women who had no prior history of cardiovascular disease.
Using an AI programme to quantify calcification and hardening in the arteries, they found women with severe cases had two to three times the risk of developing potentially fatal heart attacks, stroke and heart failure.
“This was true even in younger women under 50, a group often considered low-risk, and held up after accounting for other risk factors like diabetes and smoking,” said Hari Trivedi, Emory associate professor and co-director of the university’s Health Innovation and Translational Informatics lab, who described the research as the largest study of its kind.
“We wanted to test whether AI could use this to identify women at risk of cardiovascular disease at no extra cost or inconvenience.
“”For women, this means a mammogram you’re already having could also provide important information about your heart health, prompting a conversation with your doctor about preventive steps such as cholesterol testing or medication.”
The researchers’ work was published today in the European Heart Journal, from the European Society of Cardiology, which noted that women are largely underdiagnosed and undertreated for cardiovascular disease.
They wrote that the high resolution of routine mammograms could allow for essentially automatic, direct visualisation of the arterial beds within the breasts of nearly all adult women, with calcifications easy to detect and correlated with deposits found in other parts of the body.
The researchers said that, compared with imaging of the heart’s coronary arteries, where blockages narrow and impede the flow of oxygenated blood to the heart muscle, calcifications in breast tissue affect a separate layer of the vessel, resulting in increased artery stiffness, a measure typically linked to long-term hypertension.
They described the finding as an independent predictor of cardiovascular disease and a potentially useful addition to traditional cardiovascular risk factors.
In an accompanying editorial, Lori Daniels, a cardiologist and professor of medicine at the UC San Diego School of Medicine, said that while fewer than 40 per cent of women may know their cholesterol levels, many more are up to date with their breast cancer screening.
“Two-thirds of women aged 50-69 in the European Union reported a mammogram within the prior 2 years, and in the USA, nearly 70 per cent of women aged 45 years and older were up to date with mammography according to American Cancer Society screening guidelines,” Daniels wrote.
“Breast arterial calcification has the potential to reframe this mismatch, leveraging a widely adopted cancer-screening platform to identify cardiovascular risk in women who may not otherwise engage with prevention.”
A blood test for endometriosis showed clinical promise after detecting cases missed by standard imaging, according to a clinical validation study.
HerAnova Lifesciences has published a peer-reviewed clinical validation study of its HerResolve blood test for endometriosis in the Journal of Minimally Invasive Gynecology, the official journal of the AAGL.
The multi-centre study enrolled 298 women of reproductive age across 11 clinical sites in the US, Europe and Hong Kong.
The study population was 75.8 per cent white, 9.7 per cent Black, 9.1 per cent Asian and 5 per cent non-white Hispanic participants.
It found the test identified 61.5 per cent of histologically confirmed endometriosis cases that were missed by transvaginal ultrasound and or MRI scans.
All results were validated against the gold standard of laparoscopic findings with histopathological tissue confirmation.
The headline numbers were an AUC of 0.944, specificity of 97.5 per cent and sensitivity of 80 per cent. The high specificity was a deliberate design choice, with the model optimised to minimise false positives and reduce unnecessary invasive procedures. Performance was also consistent across menstrual phases.
The blood test, called HerResolve, is a multi-omic blood-based assay that combines three serum microRNA biomarkers, three protein biomarkers, one steroid hormone, patient age and BMI into a machine learning algorithm to detect endometriosis.
Farideh Bischoff, chief medical officer at HerAnova and corresponding author of the study, said: “Endometriosis has long been one of the most underdiagnosed and undertreated conditions in women’s health.
“HerResolve was designed to work alongside existing imaging and clinical evaluation, filling a critical gap in non-invasive disease detection.”
The test is currently available at select IVF and reproductive medicine centres across the US and is positioned as a triage tool, helping identify patients who may benefit from further evaluation or empirical treatment rather than replacing surgery entirely, but potentially reserving it for treatment rather than diagnosis.
A prospective validation study is underway in geographically and ethnically diverse populations, and HerAnova is also pursuing longitudinal analyses to evaluate whether the assay can monitor treatment response over time.
Endometriosis affects approximately one in 10 women of reproductive age, yet the average diagnostic delay remains six to 11 years.
The current gold standard, laparoscopic surgery, is invasive, dependent on surgeon skill and not without risk, making a reliable non-invasive alternative one of the most sought-after tools in women’s health diagnostics.
New research has revealed privacy and advice concerns surrounding tech aimed at helping women navigate the menopause.
The study, which surveyed 310 UK participants, warns that sensitive data collected from women about their health is often vulnerable to exploitation, ranging from targeted financial scams to workplace discrimination and misinformation.
With nearly one million women in the UK leaving their jobs due to menopausal symptoms, and an estimated 13m currently perimenopausal or menopausal, new digital technology has boomed, promising to provide medical advice and solutions.
However, the research identified significant security gaps in these technologies, including the lack of medical professionals on community forums, leading to the spread of unverified medical advice and misinformation.
The large-scale study, which is the first of its kind, also highlighted a growing tension between the benefits of menopause tech and the privacy risks associated with the intimate data these services collect.
Unlike fertility trackers, which have faced intense scrutiny following legal changes such as the overturning of Roe v. Wade in the US, menopause tech remains under-researched and under-regulated.
Dr Maryam Mehrnezhad, from the information security department at Royal Holloway and co-author, said: “Many women are turning to technology to navigate the diagnostic ambiguity of going through the menopause and to combat the long waiting times often associated with traditional healthcare.”
This makes the absence of trained medical professionals on these tech community forums, who can create misinformation, a real serious threat to participants.
Users we surveyed also expressed deep fears regarding data use, specifically that intimate health data, including emotional symptoms and sexual activity history, could be accessed by insurance companies or employers.
Such data types can be used to discriminate users e.g., in regarding their health insurances and in workplaces.
Dr Taylor Robinson, co-author and post-doctoral researcher at Royal Holloway, added: “Self-tracking apps are becoming essential tools for personal advocacy, allowing users to document their journeys and foster deeper self-reflection, which ultimately improves their interactions with doctors, but more needs to be done to protect those using the apps.”
As the femtech industry is projected to reach nearly US$30bn by 2032, the authors argue that developers and policymakers must prioritise privacy to ensure digital tools remain a safe resource for those experiencing the complexities of menopause.
Rebecca Jones and Sophie Hawkes, PhD students and co-authors, added that digital platforms and social media groups provide a vital lifeline by alleviating the isolation often tied to menopause, offering a dedicated space for users to share advice and validate their experiences and, with much more rigorous scrutiny on real healthcare advice, they can be a great asset for many.
This research provides crucial practical data to inform secure, user-centric design for policymakers and menopause tech developers, noting that many current apps and devices fall short of GDPR standards by making privacy notices difficult to access or understand.
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