FDA OKs Diagnostic Blood Test to Help Determine Menopausal Status
Posted on October 25, 2018
The US Food and Drug Administration (FDA) has approved Ansh Labs' PicoAMH Elisa diagnostic test to help determine a woman's menopausal status.
The PicoAMH Elisa test measures anti-Müllerian hormone (AMH), a marker of ovarian function, and is meant to be used in conjunction with other clinical assessments and laboratory findings.
Data from 690 women aged 42 to 62 years showed that the PicoAMH Elisa test performed "reasonably well" at determining blood AMH levels and identifying women who had their last menstrual period and women who were more than 5 years away from their last menstrual period, the FDA said in a news release.
"Diagnostic results about a woman's menopausal status may prompt discussions about preventative care for women experiencing menopausal symptoms. 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," Courtney Lias, PhD, director of the Division of Chemistry and Toxicology Devices in the FDA's Center for Devices and Radiological Health, said in the release.
"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," the agency advises. The 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 reviewed the PicoAMH Elisa test through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices of a new type.
Along with this authorization, the FDA is establishing "special controls" that set forth the agency's expectations in assuring 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 said.