Med-Tech Innovation February 5, 2024
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.
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...
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