The Food and Drug Administration (FDA) has granted marketing clearance for the PicoAMH ELISA diagnostic test 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 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 ageing, 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…
