MetaMedical™ Solutions Inc

Roche wins CE mark for PCOS diagnostic immunoassay

Roche Diagnostics has received a CE mark for Elecsys anti-müllerian hormone (AMH) plus immunoassay as a diagnostic blood test for PCOS.

AMH is produced by granulosa cells in ovarian follicles. In patients with PCOS, there is an increased number of high AMH-producing follicles. Studies have shown that a high level of AMH can be used to diagnose PCOS.

PCOS is a chronic condition that can cause hormonal imbalances, irregular periods, infertility, excess androgen levels and cysts in the ovaries. There is no treatment for the disease, but the symptoms can be improved through lifestyle modification, medications, and fertility treatments.

As per the World Health Organization (WHO), approximately 8%–13% of women of reproductive age have PCOS, and up to 70% of these cases are undiagnosed. PCOS is currently through a combination of blood tests, including hormone profile, ultrasound, and patient history. Often the diagnosis is made by the exclusion of other conditions.

Verity PCOS UK chair Rachel Morman stated multiple reasons for the underdiagnosis of PCOS: “There are many layered and complex reasons for this, and one of those is the 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.”

There has been a growing interest and investment in women’s health. The North American women’s health market is forecast to be worth $170.4m in 2025, as per GlobalData analysis.

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By GlobalData

Roche’s Elecsys AMH blood test has been approved as a fertility marker to assess ovarian reserve levels. The test identifies the presence of polycystic ovarian morphology (PCOM) in women with suspected PCOS.

Another company developing a PCOS diagnostic test is US-based Metabolon. In December 2023, the company received a US National Institute of Health (NIH) award to develop the PCOS diagnostic. Metabolon’s 12-month-long PCOS project is currently ongoing. The company also has plans to apply for additional grants to build on the current PCOS project.

Other Elecsys tests in Roche’s portfolio include Elecsys HBeAg quant, to diagnose and monitor hepatitis B, Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for detecting hepatitis E virus (HEV) infections, neurofilament light chain (NfL) test for diagnosing multiple sclerosis test and interleukin 6 (IL-6) immunoassay for diagnosing neonatal sepsis.

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