24 October 2018 - Today, the U.S. FDA permitted marketing of the PicoAMH Elisa diagnostic test as an aid in the determination of a patient’s menopausal status.

The PicoAMH Elisa test measures the amount of Anti-Müllerian Hormone (AMH) in the blood. AMH levels represent one indicator available to clinicians to determine whether a woman is approaching or is likely to have reached her final menstrual period. The PicoAMH Elisa test is meant to be used only in conjunction with other clinical assessments and laboratory findings.

The FDA reviewed data submitted by the sponsor that included 690 women, aged 42 to 62, who participated in the multi-center, longitudinal Study of Women’s Health Across the Nation. 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.

Read FDA press release