Could Roche’s test change the way we diagnose PCOS?

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

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.