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 polycystic ovary syndrome (PCOS) as an alternative to a transvaginal ultrasound.
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PCOS
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 aims to enable more patients with suspected PCOS to receive an easier and faster diagnosis while removing barriers often posed by transvaginal ultrasounds such as discomfort, and cultural sensitivities.
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, added: “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, added: “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.”
