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Menopausal Status Test Granted De Novo Clearance by FDA

NEW YORK (360Dx) – The US Food and Drug Administration said on Wednesday that it has granted marketing clearance for the Ansh Labs PicoAMH ELISA diagnostic test as an aid in determining a patient’s menopausal status.

The agency granted clearance of the Webster, Texas-based company's test through the de novo premarket review regulatory pathway for low-to-moderate-risk devices of a new type.

The PicoAMH ELISA test measures the amount of Anti-Müllerian hormone in the blood, which is one indicator to determine whether a woman is approaching or is likely to have reached her final menstrual period.

The agency said it reviewed data submitted for 690 women, aged 42 to 62, who participated in the multicenter, 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 in identifying women who had their last menstrual period, and women who were more than five years away from their last menstrual period, the FDA said.

It noted that clinicians should carefully evaluate the 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. Further, 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.

Along with authorization of the Ansh test, the FDA said that it is establishing criteria, called special controls, which 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.

"Diagnostic results about a woman’s menopausal status may prompt discussions about preventative care for women experiencing menopausal symptoms," Courtney Lias, director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health, said in a statement. "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."