Diagnosis
Round up: US$11m to accelerate breakthroughs in breast cancer research, world’s first whole-genome and transcriptome test, and more
Femtech World explores the latest developments in business in the world of women’s health.
US$11m to accelerate breakthroughs in breast cancer research
Breast cancer organisation Susan G. Komen has announced today that it is awarding US$10.8m in new research grants to help propel innovation in breast cancer research.
The research grants will support 25 cutting-edge projects at 17 institutions.
Through this research investment, Komen is prioritising metastatic breast cancer, health inequities and the need for more precise, personalised treatment strategies to improve care and outcomes for everyone impacted by breast cancer.
So far, Komen’s 2025 research investment has seen 54 per cent of funding targets metastatic breast cancer, 50 per cent focused on precision medicine to tailor treatments to each patient’s unique biology, 21 per cent invested in addressing disparities to eliminate inequities in breast cancer care and outcomes, and 25 researchers funded, including 10 early-career investigators, representing the next generation of scientific leaders.
Juniper Genomics develops world’s first whole-genome and transcriptome test
Health tech company Juniper Genomics recently announced its public launch alongside a US$4.6m seed round.
Founded by experts in genomics, reproductive medicine, and bioethics, Juniper says its mission is to help patients shorten their IVF journey by offering more clarity and confidence on the first transfer.
Juniper’s proprietary platform combines whole genome and transcriptome sequencing with trio analysis, including both biological parents, to provide the most complete, clinically-relevant, and ethically responsible insights into each embryo’s health.
The single test replaces almost all existing forms of preimplantation genetic testing, and adds analysing thousands of clinically relevant genetic variants linked to IVF failure, miscarriage, and medical conditions after birth.
The test provides a clear, detailed and actionable view of embryo health and viability, screening for specific genetic changes known to cause adverse pregnancy outcomes and serious health conditions.
It is currently rolling out in early adopter clinics across North America.
Berry Fertility launches Smart Compose for patient support
Patient management platform for IVF, IUI, embryo transfer, and egg freezing, Berry Fertility, has announced the launch of its AI-powered Smart Compose tool for patient communications.
Smart Compose is designed to integrate seamlessly into existing workflows and EMRs, supporting care teams without disrupting their day-to-day operations, pulling relevant chart details, reviews patient messages, and references history to create a message draft that clinical staff can review and tweak before responding to patients.
According to the company, Smart Compose is purpose-built for the unique needs of fertility clinics and care teams, drawing on proprietary, vetted fertility content and a medication database developed by Berry Fertility.
Beyond EMR integration, Smart Compose can incorporate staff names, clinic locations, medication preferences, appointment calendars, and preferred educational materials to deliver the most accurate and relevant information.
And while Smart Compose adapts to each provider’s needs, their data remains isolated–ensuring that proprietary workflows are never shared or used to improve any other system. While it can understand patient data via workflow integrations, no AI models are trained on patient data. The result is innovative conversational technology, with safeguarded, secure guardrails.
Progyny adds pelvic floor therapy to its offerings
Women’s health company Progyny has announced that it has added digital pelvic floor therapy to its offering of women’s health solutions.
The therapy offers virtual and in-person support options for treatment and coaching, enabling earlier interventions for pelvic conditions and helping avoid delays that could lead to higher acuity treatments, surgeries, or increased healthcare costs for employers.
Progyny will be offering Origin and Hinge Health to its offering. With Origin, Progyny members can access Origin’s nationwide in-network pelvic floor physical therapy, providing evidence-based treatment for pelvic health needs including common concerns like leaky bladder, painful sex, and postpartum recovery, and more complex conditions including hysterectomy recovery, endometriosis, PCOS, and chronic pelvic pain.
With Hinge Health, members will receive digital care supported by physical therapists specialising in pelvic health and musculoskeletal (MSK) care.
Each individual will follow a personalised plan with guided exercises targeting their unique symptoms, including pelvic pain, a lack of pelvic strength or bladder control, and issues associated with menopause.
US$65m for at-home STI test
Diagnostics company Visby Medical recently raised approximately US$55m in its latest financing round.
According to the company, the funds will accelerate the launch and distribution of Visby Medical’s recently FDA-authorised at-home Women’s Sexual Health Test.
Catalio Capital Management, a leading innovative healthcare investment firm, will enhance Visby Medical’s market reach and operational capabilities. As part of the funding round, Catalio Partner Isaac Ro, will join Visby Medical’s board as an observer.
Chuck Alpuche, Chief Operating Officer at Imperative Care, former EVP and Chief Operating Officer at Insulet Corporation, and senior executive at PepsiCo, will also join Visby Medical’s board as an independent director.
According to Visby Medical, its at-home Women’s Sexual Health Test is the first single-use, disposable PCR diagnostic that delivers results within 30 minutes through a connected smartphone app.
Upon receiving positive results, users are connected with telemedicine providers for consultation and treatment, enhancing healthcare accessibility and privacy. The product will be available starting July 2025 through major direct-to-consumer channels.
Gates Foundations awards US$1.9m for preeclampsia treatment
Beech Biotech has received a grant of US$1.9m from the Bill and Melinda Gates Foundation to advance its preeclampsia treatment.
The company is developing “mother only” monoclonals to treat complications of pregnancy, and, according to Beech Biotech, its lead asset – MOm303 – binds and eliminates maternal sFlt-1, targeting a key driver of disease pathology.
The company has said that the funding will help advance the asset for IND-approval.
€4.5m raised for pelvic organ prolapse device
Medical device company Escala Medical has been granted €4.5m to support commercialisation activities for Medit – the company’s pelvic organ prolapse device.
The FDA-cleared device enables the restoration of pelvic floor function within 10 minutes using an incision-free, outpatient procedure.
The funds were awarded from the European Innovation Council (EIC) and other investors.
According to the company, the funds will support expansion into Europe and further international growth in Southeast Asia.
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.
Entrepreneur1 week agoKOVE Medical raises €1.7 million to improve safety of foetal surgery
Pregnancy1 week agoUK study aims to transform maternity care for high-risk pregnancies
Mental health2 weeks agoPMDD after SSRIs or hormones: Why the brain may be the missing treatment target
Events4 days agoLast chance to save on Women’s Health Week and Women’s Sport Summit: Early Bird pricing ends 11 September
Diagnosis2 weeks agoArk Surgical secures further institutional backing to accelerate US expansion
Fertility21 hours agoParacetamol use may impact future fertility, studies suggest
Menopause7 days agoMenopause hormone treatment may ease brain fog, study suggests
Motherhood2 weeks agoThousands of UK women develop undiagnosed PTSD after childbirth each year – study