The website of the Clinical Services Journal

New diagnostic method approved for underdiagnosed condition

The use of a blood biomarker test in a new diagnostic approach is offering fresh potential to increase the speed and accessibility of testing for polycystic ovary syndrome (PCOS), in a first-of-its-kind use for the diagnostic tool.

Roche Diagnostics has announced CE mark approval for a claim extension to the Elecsys Anti-Müllerian Hormone (AMH) Plus immunoassay. The claim extension means that the blood test, already available on the NHS, can now be used by physicians to help diagnose women suspected of having PCOS as an alternative to a transvaginal ultrasound.

The test, which is currently used as a fertility indicator, identifies the presence of polycystic ovarian morphology (PCOM) in women with suspected PCOS. PCOM is an indicator of PCOS.

The claim extension follows an update in 2023 to the Rotterdam Criteria, the global guidance for diagnosing PCOS. The guidance now recommends that elevated AMH levels can be used to detect PCOM. Previously the only recommended indicator for PCOM was counting the number of follicles per ovary by transvaginal ultrasound.

PCOS affects an estimated one in eight women of reproductive age, and has reproductive, metabolic, and psychological consequences. Up to 70% of women living with PCOS remain undiagnosed.

The blood test will enable more patients with suspected PCOS to receive an easier and faster diagnosis while also removing barriers often posed by transvaginal ultrasounds such as discomfort, and cultural sensitivities. Additionally, transvaginal ultrasounds may not always be appropriate for some people who are not yet sexually active.

Unfortunately, many women suffering from PCOS are not diagnosed or diagnosed at a late stage. While there is no cure for PCOS, earlier diagnosis of the disease can ensure patients receive targeted therapy and are encouraged to make lifestyle choices to reduce the risk of developing long-term conditions, such as type 2 diabetes.

Dr. Ashton Harper, Head of Medical Affairs at Roche Diagnostics UK and Ireland, said: “I’m really pleased that we’re able to offer this innovative use of the Roche Elecsys Anti-Müllerian Hormone (AMH) Plus immunoassay as a more accessible alternative for diagnosing PCOS.

“With the vast majority of women with PCOS going undiagnosed, it’s critical that we make diagnosis as easy and comfortable for all that need it.”

Dr. Anne Connolly MBE, General Practitioner with a special interest in gynaecology, said: “This test is great news for women and for the clinicians who care for them – supporting earlier diagnosis and reducing the short- and long-term consequences of PCOS.

“PCOS is such a common condition but too often it goes undiagnosed. Transvaginal ultrasounds can be daunting for some patients, so with the update of the Rotterdam criteria, it’s great that there’s now an alternative method of testing. It's long overdue.”

Rachel Morman, Chair, Verity PCOS UK, said: “We know that early diagnosis is a key component in improving health outcomes and quality of life in those with PCOS.  We also know that almost three quarters of the 1 in 8 that have the condition remain undiagnosed. There are many layered and complex reasons for this, and one of those is unsuitability of an internal ultrasound for many; be it due to cultural or religious sensitivity, not yet being sexually active or sadly even previous sexual trauma. 

“We welcome the AMH blood test as an option for helping some women and people living with PCOS have an easier path to diagnosis.”

Upcoming Events

Central Sterilising Club - Annual Scientific Meeting 2024

Crowne Plaza at Gerrard’s Cross
15th April 2024 – 16th April 2024

DECON UK 2024

National Conference Centre, Birmingham
17th April 2024

Infection Prevention & Control

National Conference Centre, Birmingham
23rd - 24th April 2024

ESGE Days 2024, Symposium – ‘Elevating Endoscopy: Inspiring Progress and Innovation’

Estrel Congress Center (room 15), Berlin, Germany
25th April 2024, 16:30 – 17:30 CEST

Theatres & Decontamination Conference 2024

Coventry Building Society Arena
16th May 2024

The AfPP Roadshow - Birmingham

Millennium Point, Birmingham
18th May 2024

Access the latest issue of Clinical Services Journal on your mobile device together with an archive of back issues.

Download the FREE Clinical Services Journal app from your device's App store

Upcoming Events

Central Sterilising Club - Annual Scientific Meeting 2024

Crowne Plaza at Gerrard’s Cross
15th April 2024 – 16th April 2024

DECON UK 2024

National Conference Centre, Birmingham
17th April 2024

Infection Prevention & Control

National Conference Centre, Birmingham
23rd - 24th April 2024

ESGE Days 2024, Symposium – ‘Elevating Endoscopy: Inspiring Progress and Innovation’

Estrel Congress Center (room 15), Berlin, Germany
25th April 2024, 16:30 – 17:30 CEST

Theatres & Decontamination Conference 2024

Coventry Building Society Arena
16th May 2024

The AfPP Roadshow - Birmingham

Millennium Point, Birmingham
18th May 2024

Access the latest issue of Clinical Services Journal on your mobile device together with an archive of back issues.

Download the FREE Clinical Services Journal app from your device's App store

Step Communications Ltd, Step House, North Farm Road, Tunbridge Wells, Kent TN2 3DR
Tel: 01892 779999
www.step-communications.com
© 2024 Step Communications Ltd. Registered in England. Registration Number 3893025