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Roche Nabs CE Mark for Claim Extension on Anti-Müllerian Hormone Assay

NEW YORK – Roche announced on Tuesday that it has received CE marking for a claim extension on its Elecsys Anti-Müllerian Hormone (AMH) Plus test.

The claim extension allows the fully automated immunoassay to be used to identify polycystic ovarian morphology (PCOM) in people with suspected polycystic ovary syndrome, Roche said in a statement. The AMH biomarker can now replace transvaginal ultrasound to determine PCOM in adults, the Basel, Switzerland-based company added.

The new claim extension builds on the test's previous CE marking for use in people undergoing fertility treatment, including quantifying levels of AMH in human serum and plasma to assess a patient's ovarian reserve and to predict response to controlled ovarian stimulation, Roche said. The blood test is also used to establish the individual daily dose of the human recombinant follicle-stimulating hormone follitropin delta in people undergoing ovarian stimulation.