FDA Approves Marketing of New Test to Help Dx Menopause

Test measures level of anti-Mullerian hormone in a woman's blood



The FDA approved marketing of a diagnostic test that could help clinicians in determining a woman's menopausal status, the agency said.

Ansh Labs' PicoAMH Elisa test measures the amount of anti-Müllerian hormone (AMH) in the blood, which the FDA described as "one indicator available to clinicians" to determine whether a woman is either approaching or has reached her final menstrual period.

"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," said Courtney Lias, PhD, director of the Division of Chemistry and Toxicology Devices in the FDA's Center for Devices and Radiological Health, in the FDA's press release announcing the approval.

The test was approved based on the results of a multi-center longitudinal study of 690 women that showed the PicoAMH Elisa test performed "reasonably well" at identifying the levels of AMH in a woman's blood, as well as pinpointing women who had their last menstrual period or were more than five years away from their last menstrual period.

They noted that these results should be evaluated in the context of a full clinical work-up and that the test should not be used to assess a woman's fertility status or "predict ovarian response" in women who are undergoing or have plans to undergo fertility treatments

The test was approved under the FDA's de novo premarket review pathway for "low-to-moderate risk devices of a new type."

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