Cancer
Round up: FDA clearance for AI-powered embryo assessment tool
Femtech World explores the latest developments in the world of technology and women’s health.
30-minute non-invasive test to revolutionise endometriosis detection
A new diagnostic tool for endometriosis will now be available in Canada.
EndoDiagnosis will be the sole distributor in Canada for the ENDOSURE Tier 1 diagnostic test for the condition, which cuts down the average diagnosis time from over eight years to just 30 minutes.
In the past, diagnosing endometriosis required invasive laparoscopic surgery. This often meant that patients endured years of pain and a lower quality of life without a proper diagnosis.
The ENDOSURE test offers a non-invasive option, boasting 99 per cent accuracy in detecting all stages of the disease in less than an hour. This bypasses the need for surgical procedures.
The ENDOSURE Tier 1 test is designed for women of any age and provides results on the spot without the need for referrals or lab work.
Its non-invasive nature not only spares patients from unnecessary surgical procedures but also enables healthcare professionals to concentrate on therapeutic strategies to manage the disease, preserving both quality of life and fertility.
EndoDiagnosis offers training and certification for healthcare providers, professional medical education, and awareness programmes, along with a provider directory to help patients find testing centres.
AutoIVF awarded NIH SBIR grant to advance OvaReady
Fertility technology company AutoIVF has been awarded a Phase IIB Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH).
The award is supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development.
The NIH grant will support commercialisation of AutoIVF’s flagship platform, OvaReady, an automated desktop system intended to streamline the egg identification and preparation process for in vitro fertilization (IVF).
The platform is being developed to support the decentralization of egg retrieval, with the goal of expanding access to fertility care beyond traditional IVF lab settings.
The device is currently in development
“The NIH’s sustained support over the past five years – from early feasibility to commercialization- reinforces the scientific merit and clinical potential of our approach,” said Emre Ozkumur, vice president of R&D at AutoIVF.
“We’re proud to be driving innovations intended to improve care for patients undergoing infertility treatment or fertility preservation.”
“Being selected through the NIH’s highly competitive review process shows the real potential the technology has to improve outcomes for patients, doctors, and the broader fertility field,” said co-founders Drs. Thomas Toth, Michael Alper, and Alan Penzias.
“With decades of experience as IVF physicians, we see OvaReady as a game changer – making it easier and more efficient to identify and prepare eggs for IVF and fertility preservation.”
FDA clearance for AI-powered embryo assessment tool
Reproductive care company Fairtility has confirmed that its CHLOE platform has achieved U.S. Food and Drug Administration (FDA) 510(k) clearance for one of its AI-powered embryo assessment tools, CHLOE Blast.
The clearance makes it the first and only FDA-cleared machine learning AI-powered clinical decision support software for embryo assessment.
The embryo assessment function of CHLOE analyses time-lapse embryo images to enable more objective and consistent evaluations.
Using clinical evidence, the CHLOE suite is designed to enhance the standard of care by improving workflow efficiency and bringing transparency to the IVF patient’s journey.
CHLOE supports embryologists with consistent embryo and oocyte assessments, helps doctors communicate more clearly with patients, provides management with data-driven visibility and empowers patients with greater transparency and engagement.
“This FDA clearance is more than a regulatory milestone,” said Moti Shniberg, founder of Nacre Capital, an investor in Fairtility.
“It reflects Fairtility’s leadership in bringing AI into reproductive medicine and marks the beginning of a new era of standardization, transparency, and improved outcomes for patients and clinics alike.”
PCOS fertility programme to offer tech-enabled coaching
Bellwether Wellness and Zone Labs have announced the launch of PCOSynergy, the first fertility programme for women with Polycystic Ovary Syndrome (PCOS) to unite biomarker technology with the proven science of metabolic engineering.
PCOSynergy shifts the focus from waiting for answers to taking proactive steps women can control today: improving metabolic health, reducing inflammation, and building confidence through structured coaching and tech-enabled tracking.
The programme features weekly video learning and tech-enabled biomarker tracking, group coaching and community support, and personalised one-on-one onboarding and data-informed monthly guidance.
This feature underscores that PCOSynergy provides ongoing individualised coaching, not just initial onboarding.
The platform also introduces a first-of-its-kind coaching-based promise: If participants in the extended programme do not achieve pregnancy, their tuition fees will be refunded.
“This is a game-changing moment for women with PCOS,” explains Christine Updegraff, CEO of Bellwether Wellness.
Together with Zone Labs, we’re delivering the tools, nutritional science, and compassionate support women need to move forward with clarity and confidence.
Approval for companion diagnostic test to identify HER2-ultralow breast cancer
Roche has received CE IVDR approval for two label expansions for its VENTANA HER2 Rabbit Monoclonal Primary Antibody RxDx* assay.
HER2 is a receptor protein expressed in a variety of cancers and serves as a predictive biomarker to help determine if a patient will respond to HER2-targeted therapy.
The VENTANA HER2 test is the first and only companion diagnostic approved to identify patients with HR-positive metastatic breast cancer that are HER2-ultralow.
These patients may be eligible for treatment with ENHERTU (trastuzumab deruxtecan), a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.
In addition, this test is now the first and only companion diagnostic to aid in the assessment of HER2-positive status to identify biliary tract cancer patients with an immunohistochemistry score of 3+ who are eligible for treatment with Jazz Pharmaceuticals’ ZIIHERA.
The VENTANA HER2 test was used in the DESTINY-Breast06 trial, which demonstrated a significant improvement in progression-free survival with ENHERTU compared to standard of care chemotherapy in patients with HER2-low and HER2-ultralow metastatic breast cancer.
The assay delivers timely, clear and reliable results, driving diagnostic certainty and enabling therapeutic decisions that can lead to better outcomes for patients.
The test is used in combination with the fully automated VENTANA BenchMark slide staining instrument.
An AI tool could help spot breast cancer risk by analysing how individual breast cells behave when squeezed under stress, research suggests.
Researchers at City of Hope and the University of California, Berkeley, created a microfluidic platform that assesses women’s breast cancer risk at the cellular level.
The platform squeezes individual breast epithelial cells, which line breast tissue, to measure how they deform, recover and behave under stress.
Because more than 90 per cent of women do not have a known genetic predisposition to breast cancer or a family history of the disease, the researchers said the approach could help fill a key gap in risk assessment.
Mark LaBarge, professor in the department of population sciences at City of Hope, said: “For women with a known genetic risk factor for breast cancer, there are things you can do like follow a higher-risk screening protocol. For everybody else, you’re left wondering, ‘Am I at high risk?’
“By translating physical changes in cells into quantifiable data, this tool gives women something tangible to discuss with their doctors, not just risk estimates, but evidence drawn directly from their own cells.”
The researchers developed a machine learning algorithm that identifies and measures cells showing signs of accelerated ageing, generating an individual breast cancer risk score.
They said the platform uses simple electronics that could be easy and affordable to replicate on a large scale.
Lydia Sohn, chair in mechanical engineering at UC Berkeley, said: “Our team isn’t the first to measure the mechanical properties of cells; however, other approaches require advanced imaging technology that’s expensive, cumbersome and has limited availability.
“In contrast, MechanoAge uses computer chips that are simpler than an Apple Watch and ‘RadioShack parts’ that are cheap and easy to assemble, potentially making the device highly scalable.”
About 6 per cent of women who develop breast cancer carry known genetic mutations.
For women outside this group, risk is usually estimated indirectly using population models or measures such as breast density, which can both overestimate and underestimate individual risk.
The researchers said there is currently no non-genetic test that can identify women at higher risk of breast cancer.
Screening mammograms can detect cancer only once it has started to grow, but the MechanoAge platform aims to assess risk earlier by looking for physical changes in individual cells.
Using the platform, the researchers found that breast cells appear to have a “mechanical age” separate from a person’s chronological age, based on how the cells respond to stress.
They said this is the first time mechanical age has been quantified in biological cells.
Sohn said: “We learned that the older the mechanical age, as determined by how cells respond to being squeezed through our microfluidic device, the higher the risk for breast cancer.”
In this type of mechano-node-pore sensing, an electrical current is measured across a liquid-filled channel.
As cells pass through, they disrupt the current, generating measurements about their size and shape. By narrowing parts of the channel, researchers squeeze the cells and then measure how long each one takes to return to its normal shape.
The team found that cells from older women were stiffer and took longer to bounce back after being squeezed.
They also identified a subset of younger women whose cells behaved more like those from older women. These cells came from women with genetic mutations linked to a higher breast cancer risk.
The researchers then refined the algorithm to assign a risk score based on the cells’ measured mechanical and physical properties. They said it successfully identified women with known genetic risks.
The team then used it to compare cells from healthy women, women with a family history of breast cancer, and cells taken from the healthy breast of women with breast cancer in the other breast.
LaBarge said: “With accuracy, we were able to figure out which women were at high risk of breast cancer and which women didn’t seem to be.”
The work grew out of more than 12 years of collaboration between the two labs, combining engineering with cancer and ageing biology.
Sohn said: “It’s a true collaboration. We’ve learned a lot from each other.
LaBarge added: “In my view, this is what happens when you have a real collaboration that develops over a long time. This result is not what we imagined at the beginning.”
An experimental drug slowed triple-negative breast cancer in mice by flooding tumour cells with toxic fats.
Triple-negative breast cancer lacks three common drug targets, making it one of the hardest-to-treat and most aggressive forms of the disease.
The compound, known as DH20931, appears to push cancer cells past their limits by triggering a surge in ceramides, fat-like molecules that place the cells under intense stress until they self-destruct.
In lab experiments, the drug also made standard chemotherapy more effective. When combined with doxorubicin, researchers were able to reduce the dose needed to kill cancer cells by about fivefold.
The drug targets an enzyme known as CerS2 to sharply increase production of these lipids and stress cancer cells. Healthy cells, by contrast, showed lower sensitivity to the drug in lab tests.
While the early results are promising, further preclinical and clinical trials would still be needed to determine the safety and effectiveness of DH20931 in humans.
Satya Narayan, a professor in the University of Florida’s College of Medicine, led the study with an international group of collaborators.
The researchers published their results on human-derived tumours on 21 April and presented their findings on combination therapy at the annual meeting of the American Association for Cancer Research in San Diego.
Narayan likened the drug’s effects to a home’s electrical system handling a power surge.
While healthy cells act like a properly grounded and installed circuit, cancer cells are more like a jumble of mismatched wires and faulty fuses. DH20931 overwhelms cells not with electricity, but with fats.
He said: “When that surge goes into the cancer cells, they cannot handle the amount of power they are getting. The fuses burn out, the cell can’t handle the surge and it dies.”
The compound was developed at the University of Florida in the lab of Sukwong Hong.
Hong, now a professor at the Gwangju Institute of Science and Technology in South Korea, created DH20931 as one of many drug candidates tested for efficacy in Narayan’s lab.
In the study, researchers implanted human triple-negative breast cancer tumours into mice and treated them with DH20931.
The drug significantly slowed tumour growth without causing noticeable weight loss or signs of toxicity in the animals. In separate lab experiments, it also showed activity against other breast cancer subtypes.
In addition to increasing lipid levels, DH20931 triggers a second stress signal by flooding cells with calcium.
Together, these effects disrupt the mitochondria, the structures that produce a cell’s energy, ultimately leading to cell death.
Narayan said: “It does not just follow one pathway but it goes through multiple pathways. It’s a two-hit hypothesis.
“These pathways are common in all breast cancer types and other solid tumours, so we think this drug can be useful not only in triple-negative breast cancer but potentially other cancers as well.”
Cervical cancer elimination in the EU is becoming achievable as HPV vaccination coverage rises, a new report says.
As Europe marks European Immunisation Week 2026, the European Centre for Disease Prevention and Control said progress in human papillomavirus vaccination is continuing across the EU and European Economic Area.
All EU and European Economic Area countries now recommend HPV vaccination for adolescent girls and boys as part of their immunisation programmes, marking a major step forward in Europe’s cancer prevention efforts.
Bruno Ciancio, head of unit, directly transmitted diseases and vaccine preventable diseases at the European Centre for Disease Prevention and Control, said: “The elimination of cervical cancer in the EU/EEA is becoming an achievable goal, thanks to the HPV vaccination programmes.
“The progress we are seeing across Europe demonstrates what can be accomplished when countries invest consistently in effective immunisation strategies.
“We are closely monitoring this progress and actively supporting countries to accelerate uptake and move faster towards cervical cancer elimination.”
According to the report, three EU and European Economic Area countries, Iceland, Portugal and Norway, have reached the 2024 EU Council Recommendation target of 90 per cent HPV vaccination coverage among girls by the age of 15.
Fifteen years after HPV vaccination programmes were introduced in Europe, a growing body of evidence confirms the vaccine is highly effective in preventing cervical cancer.
Large-scale studies from Sweden, the Netherlands and Denmark, as well as other parts of the world, have shown significant reductions in HPV infections and precancerous lesions, which are abnormal cell changes that can develop into cancer if left untreated, alongside falling cervical cancer rates among vaccinated women.
Since 2020, European countries have reported a decreased incidence of cervical cancer among vaccinated women.
Studies from Sweden, Denmark and the UK show that early administration of the vaccine increases its full protective potential.
A Swedish study suggested that vaccinating girls before their 17th birthday reduced the incidence of cervical cancer by 88 per cent.
An additional six-year follow-up found a sustained reduction in cervical cancer risk and a population-level decline in invasive cervical cancer incidence after HPV vaccination.
The report showed that vaccination programmes and health system design are critical factors in reaching high levels of HPV vaccination coverage.
Evidence from across Europe showed that school-based vaccination programmes are particularly effective and tend to reach higher levels of coverage among both girls and boys.
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