FDA Approves Menopausal Status Test

The FDA has approved a test to help determine a patient’s menopausal status.

The PicoAMH Elisa diagnostic test measures levels of Anti-Müllerian Hormone (AMH), which represent one indicator of reaching final menstrual period. It is meant to be used in conjunction with other clinical assessments and findings.

The approval was based upon a review of data submitted to the FDA that included 690 women, aged 42 to 62 who participated in the Study of Women’s Health Across the Nation. Overall, the data showed that the PicoAMH Elisa test “performed reasonably well at determining levels of AMH in the blood and identifying women who had their last menstrual period and women who were more than five years away from their last menstrual period.”

“Clinicians should carefully evaluate PicoAMH Elisa test results in the context of a full clinical work up 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,” they noted.

—Michael Potts

Reference:

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status [press release]. October 24, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624284.htm.