Roche Receives Expanded CE Mark for Elecsys AMH Plus Test to Aid in PCOS Diagnosis
Roche
Oncology Drug Research, Development, and Manufacturing
Source: 360Dx
On November 16, Roche announced on Tuesday that its Elecsys Anti-Müllerian Hormone (AMH) Plus test had received the CE Mark extension.
Roche said in a statement that the claim extension allows the fully automated immunoassay to be used for identifying polycystic ovary morphology (PCOM) in patients suspected of having polycystic ovary syndrome. The Basel, Switzerland-based company added that the AMH biomarker can now replace transvaginal ultrasound for determining PCOM in adults.
Roche says the new extended indication builds on the test’s prior CE Mark approval, which is indicated for use in people undergoing fertility treatment, including quantifying AMH levels in human serum and plasma to assess a patient's ovarian reserve and predict response to controlled ovarian stimulation. The blood test can also be used to determine the individual daily dose of the recombinant follicle-stimulating hormone, follitropin delta, for those receiving ovarian stimulation treatment.
