The Food and Drug Administration (FDA) has granted marketing clearance for the PicoAMH ELISA diagnostic test (Ansh Labs) used to help determine a patient’s menopausal status.

“This test, when used in conjunction with other clinical assessments and laboratory findings, can help inform discussions about preventative care, such as ways to help prevent loss in bone mineral density or to address cardiovascular disease, both of which are known to increase after menopause,” stated Courtney Lias, PhD, director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health.

The test measures levels of Anti-Müllerian Hormone (AMH) in the blood, which can be used to predict menopausal transition and ovarian aging, in conjunction with other clinical evaluations and lab findings. The FDA’s marketing approval was supported by data from 690 women (aged 42 to 62 years) who were enrolled in the Study of Women’s Health Across the Nation. Findings revealed that the PicoAMH Elisa test performed reasonably well at determining AMH levels in the blood to identify patients who had their last menstrual period and those who were >5 years away from their last menstrual period.

Test results should be assessed carefully to ensure that contraceptives are not discontinued early in women who have yet to reach menopause, and that uterine bleeding due to endometrial cancer is not dismissed as a diagnosis. The test should not be used to assess a woman’s fertility status or to monitor or predict ovarian response in those planning to undergo fertility treatments. 

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