FDA Permits Marketing for Menopausal Status Diagnostic Test

The US Food and Drug Administration (FDA) has granted permission for marketing to the PicoAMH Elisa diagnostic test as a clinical aid for determining patients’ menopausal status.

The test, which measures the amount of Anti-Müllerian Hormone (AMH) in the blood, was supported by data assessing 690 women aged 42-62 years involved in the Study of Women’s Health Across the Nation longitudinal study. It performed “reasonably well” at determining AMH levels—an indicator available to physicians to determine a woman’s pace towards her final menstrual period—and identifying women who either had their last menstrual period, or were more than 5 years away from that event.

That said, the FDA also advised the test be only used in conjunction with other clinical assessments and/or laboratory findings, and that clinicians carefully evaluate test results “to ensure that contraceptives are not discontinued in women who have not yet reached menopause and that uterine bleeding due to endometrial cancer is not dismissed as a diagnosis.”

Menopause, distinguished as the transition of varying production of estrogen and progesterone, is also characterized by women’s bones becoming less dense, lipid profiles altering, and the eventual risk of heart disease and osteoporosis in post-menopausal stage.

Being capable of providing accurate, timely diagnosis on women’s menopausal status could prompt physicians and patients to discuss preventive care in relation to these symptoms, Courtney Lias, PhD, director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health, said.

“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,” Lias said about PicoAMH.

The FDA had reviewed data for the testing device through the de novo premarket review pathway, indicating its role as a low-to-moderate-risk device of a new type.