Women who want to know if they have entered menopause — or when they will — may be able to find out with a new blood test.
The U.S. Food and Drug Administration (FDA) recently granted approval to the PicoAMH Elisa test. It’s produced by Ansh Labs.
The test works by measuring anti-Müllerian hormone (AMH), which is a marker of ovarian function. It’s supposed to be used with other clinical evaluations and laboratory findings to give physicians a better idea of a woman’s menopausal status.
The test was evaluated using data from 690 women between the ages of 42 and 62. Results showed that it performed “reasonably well” at detecting AMH levels. It also was able to pinpoint if a woman had experienced her last menstrual period, and if she was more than five years away from it.
“Diagnostic results about a woman’s menopausal status may prompt discussions about preventative care for women experiencing menopausal symptoms,” said Courtney Lias, PhD, director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health. She said the test can give doctors more information to discuss preventative care with patients. For example, it could help them gauge where a woman is, as far as menopause status, so they can prevent bone mineral density loss or cardiovascular disease. The risks of those are known to increase after menopause.
The FDA said that clinicians should evaluate the results of the test in the context of a full clinical workup to ensure 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. It shouldn’t be used as a fertility-related tool, the FDA added