The PicoAMH Elisa diagnostic test can now be marketed as an aid in the determination of a patient’s menopausal status, the FDA announced Wednesday.
The PicoAMH Elisa test measures the amount of anti-Müllerian hormone (AMH) in the blood, representing 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, according to the FDA.
“Diagnostic results about a woman’s menopausal status may prompt discussions about preventative care for women experiencing menopausal symptoms,” Courtney Lias, PhD, director of the division of chemistry and toxicology devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “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.”
The FDA reviewed data submitted by the sponsor that included 690 women aged 42 to 62 years who participated in the longitudinal SWAN study. The data demonstrated 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 5 years away from their last menstrual period, according to the release.
The FDA noted that clinicians should carefully evaluate PicoAMH Elisa test results in the context of a full clinical workup 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. The PicoAMH Elisa test should not be used to assess a woman’s fertility status or to monitor or predict the ovarian response in women undergoing or planning to undergo fertility treatments, the FDA added.
The FDA reviewed data for the PicoAMH Elisa test through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, which set forth the agency’s expectations in ensuring the accuracy, clinical performance and labeling of tests intended to be used as an aid in the determination of a patient’s menopausal status. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for these tests.
The FDA granted marketing authorization of the PicoAMH Elisa test to Ansh Labs.