Connect with us


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.

To receive the Femtech World newsletter, sign up here.

Sorina Mihaila is the Femtech World editor, covering technology, research and innovation in women's health. Sorina is also a contributor for the neuro-rehabilitation magazine NR Times.


Lawyers warn of discrimination risks around lack of menstrual health support in the workplace

Employers should consider proactively supporting women in managing menstruation at work, lawyers have argued



Employers should consider the potential discrimination risks around menstrual health in the workplace, lawyers have warned, as research shows that most women in the UK feel unsupported.

According to the Chartered Institute of Personnel and Development (CIPD), the majority of women in the UK do not feel a strong sense of support in their organisation in relation to their menstrual cycle.

Figures show women are more likely to feel supported by colleagues than by their employer or manager, with only one in 10 reporting that their organisation provides support for menstruation and menstrual health.

Annisa Khan, employment lawyer at Farrer & Co who has previously raised the alarm over the lack of practical measures to support women with their periods, told Femtech World that employers should be mindful of the legal risks related to managing menstruation.

“Under the Equality Act 2010, it is unlawful to discriminate against employees based on sex, age, or disability,” she said.

“Employers should therefore consider the potential discrimination risks in relation to managing mensuration in the workplace and implement measures to reduce these risks.”

A lack of workplace period policies has been estimated to cost businesses over £6bn per year, as menstrual symptoms cause women to miss an average of 8.4 days per year due to lower productivity.

Khan said organisations should consider proactively supporting employees in managing menstruation at work by reviewing existing policies, including sickness absence and health and wellbeing policies, to ensure they effectively address menstrual-related concerns.

“Creating an open and supportive environment is crucial for employees to feel comfortable discussing periods at work,” she explained.

“This involves raising awareness among all staff, including senior-level managers and male colleagues, to foster an understanding of how colleagues may be affected by menstruation, the relevant policies and how to have open and empathetic conversations.

“Implementing practical measures is also essential to create a supportive environment. Practical steps can include having accessible bathroom facilities with sanitary bins, providing free period products to employees, offering additional breaks and providing a quiet space for rest.”

In line with CIPD’s findings, Khan said workplaces should also consider implementing more flexible working practices and giving women more breaks when needed.

“Employers should be open to employees adjusting their work pattern on the days they are experiencing menstruation symptoms by, for example, offering employees the opportunity to work from home.

“Additionally, they should consider the needs of employees with disabilities or those with medical conditions, and how they may be affected by managing mensuration at work.”

Heidi Watson, employment partner at Clyde & Co, said employers should ensure they avoid breaching discrimination laws when approaching issues like menstrual health.

“As awareness of menstrual issues such as endometriosis grows and as employees are more willing to discuss their symptoms at work, employers will need to consider whether employees are disabled under the legal definition and therefore entitled to protection from less favourable treatment and subject to the duty of the employer to make reasonable adjustments for them,” she told Femtech World.

“Employees may also be able to establish sex or age discrimination claims. We can expect more claims to come before the Employment Tribunal in the not too distant future, in a similar way as we have seen with cases involving menopause in recent years.

“Adopting a flexible approach to managing those with menstrual symptoms which are impacting their work, and creating an open and supportive culture around the issue, will help to reduce the risk of such claims being brought,” she added.

To receive the Femtech World newsletter, sign up here.

Continue Reading


OB/GYN-founded vitamin company pledges US$10m to improve women’s health research

Perelel aims to close the divide on women’s reproductive health research and improve access to nutritional support



Alex Taylor and Victoria Thain Gioia, co-founders of Perelel

The US OB/GYN-founded vitamin company Perelel has pledged US$10m to Magee-Womens Research Institute and Good+ Foundation to fund women’s health research and address gaps in maternal healthcare.

The vitamin company said the US$10m would be distributed as both in-kind product donations and funding grants through 2027 focused on advancing women’s reproductive health.

Magee-Womens Research Institute is the largest US research foundation focused exclusively on women’s health, reproductive biology and infant research and care.

Good+Foundation is a national nonprofit working to dismantle multi-generational poverty by pairing tangible goods with innovative services for under-resourced individuals.

“As the only female OB/GYN-founded women’s vitamin company, Perelel is committed to ensuring that all women have access to medically backed care,” said Victoria Thain Gioia, co-founder and co-CEO of Perelel.

“This is why we are devoted to furthering women’s research in partnership with Magee-Womens Research Institute and creating more equity in the way underserved communities receive critical prenatal micronutrients that would otherwise be inaccessible thanks to Good+Foundation.”

Research shows that medical studies have historically excluded female participants and data have been collected from males and generalised to females.

The exclusion of women of “childbearing potential” from clinical research studies has meant that women’s diseases are often missed, misdiagnosed or remain a total mystery.

Alex Taylor, co-founder and co-CEO and of Perelel, said: “We recognise how wildly complex women’s bodies are — bodies that have historically been oversimplified, objectified and shamefully under-researched in medicine.

“Unfortunately, it’s not as simple as ’12 essential nutrients.’ In founding Perelel, we hope to shine a light on how dynamic our bodies are by supporting them with targeted solutions made by the doctors and experts who know best.

“Core to what we stand for is the need to keep fighting for our fundamental rights and help close the women’s health research gap and improve body literacy.”

Perelel’s pledge comes at a time of intensified focus on women’s health as efforts start to reach new levels, including the White House, after President Joe Biden announced the first-ever initiative on Women’s Health Research in 2023.

“It is critical that there is more in-depth medical research done to support women at every hormonal life stage,” said Michael Annichine, CEO at Magee-Womens Research Institute and Foundation.

“Perelel has committed to a cash donation to further advance research into women’s reproductive health and to ensure that this research is made more accessible to doctors everywhere.”

To receive the Femtech World newsletter, sign up here.

Continue Reading


New treatment could ‘disrupt’ growth of breast cancer tumours

A new type of immunotherapy could lead to pioneering treatment for breast cancer



A breakthrough injection could “disrupt” the growth of breast cancer tumours, paving the way for a pioneering new treatment.

Breast cancer is the most common cancer in the UK with one woman diagnosed every 10 minutes. Around 55,000 women in the UK are diagnosed with breast cancer every year and 11,500 die from the disease each year.

Researchers from the Institute of Cancer Research have found that a new type of immunotherapy that targets non-cancer cells could help prevent the growth and spread of breast cancer tumours.

The discovery, published in The Journal for ImmunoTherapy of Cancer, has found that an immunotherapy approach targeting a protein, called endosialin, disrupts the tumour’s blood supply and, as a result, can hinder its growth and spread.

Unlike most cancer treatments, this innovative treatment does not target cancer cells directly but attacks the cells that support the disease instead.

Researchers used a type of immunotherapy called CAR-T therapy, which involves removing a patient’s healthy immune cells and genetically modifying them to attack specific targets.

CAR-T therapies are already being used to treat some blood cancers, and scientists are trying to find ways to make them effective for other types of cancer, including breast cancer.

However, CAR-T cell therapy does not always work on tumours because their environment suppresses the immune response, and it can also be challenging to find specific features on the breast cancer cells to target.

To work around these challenges, the team directed the CAR-T cells to cells surrounding the tumour’s blood supply that make the endosialin protein, rather than actual cancer cells. In experiments in mice, scientists found that targeting endosialin successfully reduced the breast cancer’s growth and spread.

The team, based at the Breast Cancer Now Toby Robins Research Centre at The Institute of Cancer Research (ICR), also tested the treatment on lung cancer tumours in mice and saw similarly successful results, suggesting patients with other types of cancer could benefit from this new treatment too.

In addition, researchers found that the CAR-T therapy did not affect cells without endosialin, indicating this could work as a cancer-specific treatment with potentially fewer side effects for patients.

“This is the very first study that demonstrates the effectiveness of using endosialin-directed CAR-T cells to reduce breast cancer tumour growth and spread,” said Dr Frances Turrell, study co-leader and postdoctoral training fellow in the division of breast cancer research at the Institute of Cancer Research.

“Immunotherapy has had limited success in treating breast cancer but by targeting the cells that support the tumour and help it to survive, rather than the cancer cells directly, we’ve found a promising way to overcome the challenges posed by the tumour environment and develop a more effective and targeted treatment for breast cancer.

“We could not have done this project without funding to the Molecular Cell Biology group from Breast Cancer Now and we hope that further research will help translate these findings into targeted therapies for breast cancer patients.”

Dr Simon Vincent, director of research, support and influencing at Breast Cancer Now, said: “This exciting research could lead to much-needed targeted treatments for people with breast cancer, and with one person dying from breast cancer every 45 minutes in the UK, new treatments like these are urgently needed.

“Now we know that the treatment works in principle in mice, Breast Cancer Now researchers can continue to develop this immunotherapy to make it suitable for people, as well as to understand the full effect it could have and who it may benefit the most.”

To receive the Femtech World newsletter, sign up here.

Continue Reading


Copyright © 2023 Aspect Publishing Ltd. All Rights Reserved.