News
Could Roche’s test change the way we diagnose PCOS?
The test is hoped to increase the speed and accessibility of testing for PCOS, but could it really change the way we diagnose the condition?
Roche Diagnostics has made headlines after its diagnostic test was approved for polycystic ovary syndrome (PCOS), a condition that affects one in 10 women in the UK.
The Swiss company has received a CE mark for Elecsys anti-müllerian hormone (AMH) plus immunoassay as a diagnostic blood test for PCOS.
AMH, produced by granulosa cells in ovarian follicles, tends to be higher in patients with PCOS than in healthy women. Studies have shown that a high level of AMH can be used to diagnose PCOS.
Roche says the test is offering fresh potential to increase the speed and accessibility of testing for PCOS, but could it really change the way we diagnose the condition? Here’s what experts told Femtech World.
Dr Alex Eskander, gynaecologist at the The Gynae Centre
At the moment, a diagnostic of PCOS can be made if women meet at least two of the following criteria: irregular periods, increased androgen levels and polycystic ovaries on ultrasound. There’s no doubt that finding a high AMH above the normal level will also confirm the diagnosis.
I am in private practice, so the test is not new to me. I have to say I’ve only requested it specifically to confirm PCOS twice. However, I think it will be well-received. It’s a good tool to have.
Dr Christy Evans, OB/GYN at Almond
This is a promising development in expanding the diagnostic options that OB/GYNs can use to help clarify and guide clinical care for women who struggle with PCOS.
Using AMH as a marker for PCOS has the potential to give us a more targeted picture of the ovarian environment in a way that is faster, convenient and more comfortable for the patient than a transvaginal ultrasound.
This is really exciting and I’m looking forward to more research into this as an option in the US market.
Amy Beckley, scientist and CEO of Proov
While I do think an AHM is another good tool to have, I do not believe it has the diagnostic power to diagnose PCOS by itself. Low AMH is seen with women low ovarian reserve, low egg count and high AMH in women with PCOS, so what happens in the case of a woman with low ovarian reserve and PCOS that has a normal AMH level?
If we just rely on AMH for diagnosis, we will be missing a lot of cases of PCOS and misdiagnosing some that do not have PCOS with PCOS. I think AMH could be used as an initial screening tool but even if results are negative/normal but the woman has symptoms, she should get additional testing.
I think it could be a good way to screen many women quickly to help get medical care quicker, but I do not think normal results should rule out PCOS especially if she has symptoms.
PCOS is a very complex disorder and can present itself in a variety of ways. Therefore, we should not rely on just a single blood test hormone to diagnose PCOS. If not careful, this could lead to worse healthcare and less personalised support for women.
Dr Mary Jacobson, OB/GYN and chief medical officer at Hello Alpha
The Roche test does assist me in a small cohort of patients with either irregular periods or hyperandrogenism and without infertility with an additional option other than ultrasound.
The test raises awareness about PCOS. However, the greatest need is for improvement in education and awareness for females at birth and healthcare professionals.
Timely diagnosis is important for engaging females at birth in lifestyle management early in the life course to prevent weight gain, obesity and related metabolic complications.
Dr Santanu Acharya, consultant gynaecologist and obstetrician and ambassador of the the charity PCOS Relief
This is a welcome step since it represents a manufacturer’s declaration that products comply with the EU’s directives.
AMH as a marker for the ovarian reserve of eggs has revolutionised the management of stimulation protocols used in assisted conception treatment, increasing success rates and reducing patient risks.
Given the challenges with ultrasound in the diagnosis of PCOS, including in the years after menarche, serum AMH has been proposed as an alternative marker of polycystic morphology (PCOM). One should be aware that PCOM and PCOS are not the same.
However, the International Evidence-based Guideline for the assessment and management of polycystic ovary syndrome (2023), which has been endorsed by the American and European societies, recommend that serum AMH should not be used as a single test for the diagnosis of PCOS.
Serum AMH should not yet be used in adolescents. Either serum AMH or ultrasound may be used to define PCOM. However, both tests should not be performed to limit overdiagnosis.
Chand Kaur, founder and chief executive of PCOS Relief
With the increasing number of females being diagnosed with PCOS worldwide, it is extremely important research is being done to correctly diagnose a female with this condition sooner than later, this can support in preventing long term health conditions associated with PCOS but also psychological conditions.
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The World Health Organization (WHO) has launched an AI tool in beta to help policymakers, experts and healthcare professionals access sexual and reproductive health information faster.
Called ChatHRP, the tool was created by WHO’s Human Reproduction Programme and draws only on verified research and guidance collected by HRP and WHO.
It uses natural language processing and retrieval-augmented generation to produce referenced content and cut the time spent searching through documents across different platforms and databases.
WHO said ChatHRP also has multilingual capabilities and low-bandwidth functionality to support use in a wide range of settings.
The beta-testing phase is aimed at a broad professional audience, including policymakers, healthcare workers, researchers and civil society groups.
WHO said the tool can help users quickly access up-to-date evidence, find sources for academic work and verify information on sexual and reproductive health and rights.
Examples of questions it can answer include the latest violence against women data in Oceania for women aged 15 to 49, recommendations on managing diabetes during pregnancy, and whether PrEP and contraception can be used at the same time. PrEP is medicine used to reduce the risk of getting HIV.
WHO added that the system will be updated regularly as new HRP materials are published and includes a feedback loop so users can flag gaps in the information provided.
The launch comes amid wider concern about misinformation in sexual and reproductive health.
A 2025 scoping review found that misinformation in digital spaces is a systemic issue that can undermine human rights, reinforce discriminatory social norms and exclude marginalised voices.
The review also said misinformation can affect health systems by shaping provider knowledge and practice, disrupting service delivery and creating barriers to equitable care.
WHO said ChatHRP is intended to give users streamlined access to reliable information as a counter to “algorithms, opinions, or misinformation”.
Wellness
Women’s HealthX unveils Northwell Health, Corewell Health, Biogen & more to headline Chronic Disease stage
Women’s HealthX has announced its lineup of healthcare trailblazers speaking on Chronic Disease Management, alongside other specialisations including Fertility, Sexual Health, Maternity, Menopause and Cognitive Health, taking a holistic approach to women’s health.
It will bring together 750+ leaders across pharma, health systems, and innovation to address one of the most urgent and underexamined challenges in healthcare; the sex difference gap in data and evidence.
Since cardiovascular disease remains the leading cause of death among women globally, and autoimmune and neurological conditions affect women at significantly higher rates, Women’s HealthX will home in on chronic disease management with 17+ sessions spotlighting case studies and lessons learned.
The Chronic Disease Management Stage at Women’s HealthX responds directly to this gap, convening senior decision makers and innovators to explore how sex specific science, digital health, and new care models can reshape outcomes for women.
Attending pharma & healthcare organisations include:
- Tracy Sims, Executive Director, Cardiometabolic Health, Eli Lilly
- Adrian Kielhorn, Senior Director, Global Head HEOR Neurology, Alexion Pharmaceuticals
- Lauren Powell, Head of Health Equity and Clinical Innovation, Biogen
- Amy Kao, SVP, Head of Neuroscience and Immunology Research, EMD Serono
- Stella Vnook, Executive Chair and CEO, Kaida Biopharma
- Amanda Borsky, Director, Clinical Research, Northwell Health
- Lacey McIntosh, Division Chief, Oncologic and Molecular Imaging, UMass Memorial Medical Center
- Nicole Turck, Vice President Operations, Women’s Health, Corewell Health
- Mette Dyhrberg, CEO, Autoimmune Registry
- Lyn Agostinelli, Principal Consultant, Halloran Consulting Group
Sessions addressing the real gaps in women’s chronic care
The agenda features a series of high impact sessions tackling the structural and scientific gaps in women’s health:
- Improving outcomes in obesity through evidence based person centered care: Eli Lilly
- Tackling sex based health inequities by breaking down barriers and bias: Alexion Pharmaceuticals
- Close the health equity gap in women’s health by improving how autoimmune diseases are diagnosed, treated and managed: Autoimmune Registry
- How a GYN only care model is driving faster access to gynecological care: Corewell Health
- Transforming early detection in ovarian cancer: new pathways to accuracy, safety, and better outcomes: UMass Memorial Medical Center
Panel discussions include:
- Why chronic disease looks different in women and why health systems haven’t adapted: Biogen, Kaida Biopharma, EMD Serono
- How can we better engage with our customers: Northwell Health, Halloran Consulting Group
Health equity starts here. REGISTER YOUR PLACE
Why This Matters Now
Women’s HealthX positions chronic disease not just as a clinical challenge, but as a critical frontier for innovation, investment, and system redesign.
From AI powered monitoring and digital therapeutics to real world data and integrated care pathways, the stage highlights where meaningful progress is already being made and where the biggest opportunities lie.
For the FemTech ecosystem, this represents a pivotal moment: aligning technology, clinical insight, and commercial strategy to finally close the long standing data and care gaps in women’s health.
About Women’s HealthX
Women’s HealthX is where the transformation of women’s health begins at its true foundation: data, science, and evidence.
It’s the leading event dedicated to closing the sex difference data gap and accelerating breakthroughs through science driven, real world case studies.
Taking place on December 3 to 4, 2026 in Boston, USA, the exhibition will bring together more than 750 healthcare leaders, including clinicians, payers, employers, investors, and policymakers.
Seven different stages with 150+ expert speakers taking an holistic approach to women’s health. From fertility, maternity, sexual health, cognitive health, menopause and chronic disease, we address care at every stage of a woman’s life.
An AI atlas has mapped how reproductive organs age through menopause, with the ovaries, vagina and uterus changing on different timelines.
To better understand how this process affects health, researchers at the Barcelona Supercomputing Center developed what they describe as the first large-scale atlas of female reproductive system ageing, using artificial intelligence.
The team combined 1,112 tissue images from 659 samples, covering 304 women aged 20 to 70, with gene expression data from thousands of genes.
This allowed them to reconstruct how seven key reproductive organs, including the uterus, ovary, vagina, cervix, breast and fallopian tubes, age over time.
The study used the supercomputing power of MareNostrum 5 together with advanced image-recognition methods to process the data.
Using deep learning techniques, the researchers detected visible tissue changes as well as the underlying molecular processes linked to ageing in each organ.
The result was a detailed, organ-by-organ map of the reproductive system’s ageing process.
The researchers found that not all organs age in the same way or at the same speed. The ovaries and vagina showed a more gradual ageing process that begins even before menopause officially starts.
By contrast, the uterus appeared to undergo more sudden changes around the time of menopause.
Even within a single organ, different tissues aged at different rates. In the uterus, for example, the mucosa, its inner lining, and the muscular layer did not change in sync. These tissues also appeared to be particularly sensitive to the hormonal and biological shifts associated with menopause.
Marta Melé, leader of the transcriptomics and functional genomics group at BSC and director of the study, said: “Our results show that it acts as a turning point that profoundly reorganises other organs and tissues of the reproductive system, and allows us to identify the genes and molecular processes that could be behind these changes.”
Building on the finding that organs age according to different patterns, co-first author Laura Ventura said the research “paves the way for personalised medicine where treatments are tailored to a woman’s specific molecular profile and the specific tissues showing the most age-related distress.”
The study also identified molecular signals linked to reproductive ageing that can be detected in blood samples from more than 21,441 women.
These biomarkers could allow doctors to monitor the condition of reproductive organs in a non-invasive way, potentially helping to anticipate risks such as pelvic floor complications without the need for biopsies.
According to the researchers, this could lead to simpler and more accessible clinical tools for tracking women’s health over time.
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