Insight
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.
Nighttime temperatures during pregnancy may be linked to a higher chance of an autism diagnosis in children, a recent study suggests.
The research tracked nearly 295,000 mother-child pairs in Southern California from 2001 to 2014 and linked warmer overnight temperatures with higher risk in early and late pregnancy.
Children of mothers exposed to higher than typical nighttime temperatures during weeks one to 10 of pregnancy had a 15 per cent higher risk of an autism diagnosis.
Exposure during weeks 30 to 37 was linked to a 13 per cent higher risk.
Lead author David Luglio, a post-doctoral fellow at Tulane University, said: “A key takeaway is that we identified specific windows when a mother and her developing child can be most affected by exposures to higher nighttime temperatures.
“This is critical and hopefully can help mothers prepare accordingly.”
The study is described as the first to examine how temperature may affect fetal neurodevelopment, the process by which a baby’s brain and nervous system form during pregnancy.
Extreme temperatures linked to increased risk were classified as above the 90th percentile, meaning 3.6°F hotter than average, and the 99th percentile, 5.6°F above average.
The association held even after researchers accounted for factors such as neighbourhood conditions, vegetation and fine-particle air pollution.
The study could not account for other factors such as access to air conditioning. Researchers did not find the same association with daytime temperatures, potentially because people spend more time away from home during the day.
“Heat waves are becoming more frequent, and people may only think of the dangers of daytime heat exposure,” said Mostafijur Rahman, assistant professor of environmental health sciences at Tulane University.
“These results indicate a strong association between high nighttime temperatures during pregnancy and autism risk in children and show that we need to think about exposure to heat around the clock.”
The study did not examine how higher temperatures at night might affect prenatal development, though Luglio said it is possible that warmer nights disrupt sleep for pregnant mothers.
Previous research has suggested insufficient sleep during pregnancy may be linked to a higher risk of neurocognitive delays in children.
“Extreme heat exposure during pregnancy has been linked to a range of adverse health outcomes, including prenatal neurodevelopment delays and complications with an embryo’s development of a central nervous system,” Luglio said.
“The goal of our study was to specifically explore the link between prenatal heat exposure and autism diagnoses for the first time.”
The World Health Organization (WHO) welcomed a delegation of parliamentarians to its Geneva headquarters for a high-level dialogue on women’s health and sexual and reproductive health and rights.
The meeting on 20 January 2026 focused on women’s health, sexual and reproductive health and rights, noncommunicable diseases (long-term conditions such as cancer and diabetes) and global health cooperation.
The exchange was convened by the Konrad-Adenauer-Stiftung and the UNITE Parliamentarians Network for Global Health, bringing together parliamentarians from Albania, Germany, Georgia, Mexico, Slovakia, South Africa, Sri Lanka, Sweden and Zimbabwe.
A central theme was the need to move beyond fragmented approaches to women’s health.
Dr Alia El-Yassir, WHO director for gender, equity and diversity, highlighted that outcomes are shaped by gender inequalities, social norms and structural barriers across the life course, requiring coordinated action across health systems.
Thirty years after the Beijing Declaration and Platform for Action, a landmark framework adopted in 1995 to advance gender equality and women’s rights, Dr Anna Coates, WHO gender equality technical lead, noted that progress on women’s health remains uneven.
She called for health systems that are more gender-responsive and able to address women’s health holistically across the life course.
Parliamentarians stressed that health is inseparable from wider social and economic policies, and called for stronger links between evidence, legislation and measurable impact at country level.
The meeting also focused on sexual and reproductive health and rights, where parliamentarians expressed interest in engaging on issues that directly affect their constituents.
Dr Pascale Allotey, director of WHO’s Department of Sexual, Reproductive, Maternal, Child, Adolescent Health and Ageing, outlined WHO’s life-course approach to sexual and reproductive health and rights.
She highlighted how needs evolve from birth to older age and how these are shaped by social determinants, humanitarian crises and demographic trends.
Dr Allotey underscored the role of parliamentarians in advancing sexual and reproductive health and rights and the importance of continued engagement with WHO to support evidence-based policy-making.
The agenda highlighted cancer as a growing priority for women’s health and for health system sustainability. Dr Prebo Barango, lead for the Cervical Cancer Elimination Initiative, Dr Meghan Doherty, consultant for palliative care, and Santiago Milan, lead for the WHO Global Platform for Access to Childhood Cancer Medicine, presented WHO’s integrated approach to cancer control.
Palliative care is treatment and support that aims to improve quality of life for people with serious illness by managing pain and other symptoms.
The discussion underlined the need for sustained political commitment and domestic investment to address noncommunicable diseases.
Parliamentarians shared national experiences showing the social and economic impacts of cancer on families and caregivers, reinforcing the importance of improving health literacy, reducing stigma and delivering people-centred care.
The meeting also addressed the state of global multilateralism.
Dr Jeremy Farrar, assistant director-general for health promotion, disease prevention and care, outlined how WHO has restructured to enhance efficiency, impact and capacity to support countries.
He reaffirmed WHO’s commitment to more systematic engagement with parliaments, recognising their role in shaping health policy, legislation and budgets.
The exchange concluded with a call for continued collaboration, including through partnerships with the Konrad-Adenauer-Stiftung and the UNITE Parliamentarians Network for Global Health, ahead of the UNITE Global Summit 2026 on 6–7 March in Manila, the Philippines.
Agilent has FDA approval for a test to identify ovarian cancer patients who may be eligible for immunotherapy.
Agilent’s PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic to help identify patients with epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumours express PD-L1 and who may be eligible for treatment with KEYTRUDA, Merck’s anti-PD-1 therapy.
A companion diagnostic is a test used alongside a specific treatment to show whether a patient is suitable for that therapy. PD-L1 is a protein on some cancer cells that helps tumours evade the immune system.
These cancers affect the reproductive system and the lining of the abdominal cavity.
The test enables pathologists to assess PD-L1 expression at diagnosis to support treatment decisions in a disease where options remain limited for many.
This is the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx for use with KEYTRUDA.
Nina Green, vice president and general manager of Agilent’s clinical diagnostics division, said: “Delivering effective precision oncology requires close collaboration between diagnostics and therapeutics, and this FDA approval reflects Agilent’s long-standing industry partnership in companion diagnostics.
“We are proud to enable pathologists to identify patients with EOC who may benefit from immunotherapy.
“As the first immuno-oncology approval for this disease, this milestone underscores our commitment to advancing precision medicine and expanding access to innovative cancer treatments worldwide.”
PD-L1 expression with this test was evaluated in the KEYNOTE-B96 clinical trial supporting its use to identify patients who may benefit from KEYTRUDA.
In the US, ovarian cancer caused approximately 12,730 deaths in 2025 and the five-year survival rate was 51.6 per cent between 2015 and 2021.
In addition to these cancer types, the test is indicated in the US to help identify patients with non-small cell lung cancer, oesophageal squamous cell carcinoma, cervical cancer, head and neck squamous cell carcinoma, triple-negative breast cancer and gastric or gastro-oesophageal junction adenocarcinoma who may benefit from treatment with KEYTRUDA.
The test was developed by Agilent with Merck as a companion diagnostic for KEYTRUDA.
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