With an eye toward helping women approaching menopause and their providers make decisions regarding care, the FDA has allowed the marketing of the PicoAMH Elisa diagnostic test, which measures the amount of anti-Müllerian hormone (AMH) in the blood. The test, from Webster, Texas-based Ansh Labs LLC, aims to help determine whether a woman is approaching menopause or is likely to have had her final menstrual period. To arrive at its favorable decision, the agency examined data for the PicoAMH Elisa test through de novo premarket review, a regulatory pathway for low-to-moderate risk devices of a new type.
"Diagnostic results about a woman's menopausal status may prompt discussions about preventative care for women experiencing menopausal symptoms," said Courtney Lias, director of the Division of Chemistry and Toxicology Devices in the CDRH. "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."
In women, AMH is produced by the granulosa cells of small growing follicles from week 36 of gestation until menopause, when levels become undetectable. Further, during the menopausal transition, the body's production of estrogen and progesterone can vary. As their bones become less dense, women face a higher risk of fractures. In addition, lipid profiles may change, and that could lead to low density lipoprotein cholesterol. According to the American Heart Association, more than 1 in 3 female adults will experience some form of cardiovascular disease. The increased rate of heart attacks in women is seen about 10 years after menopause.
For its part, Ansh is a developer and manufacturer of tools for biomedical research and clinical diagnostics. Its core immunoassays have potential applications in reproductive medicine, neurodegenerative disorders and oncology, in addition to other areas. It has conducted research in growth factors, neuronal disorders, glucagon regulation and animal-specific assays.
To arrive at its decision, the FDA reviewed data that included 690 women between the ages of 42 and 62, who participated in the multicenter, longitudinal Study of Women's Health Across the Nation (SWAN). The study has looked at the physical, biological, psychological and social changes during this transitional period. 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, as well as those who were more than five years away from their last menstrual period.
The study started in 1994. Between 1996 and 1997, 3,302 participants joined SWAN through seven designated research centers in Michigan, Massachusetts, Illinois, California, New Jersey and Pennsylvania.
SWAN was conducted in three phases, with the first consisting of focus groups of women with characteristics similar to those subsequently enrolled in the study. Information obtained helped develop the study design and protocols for recruiting and retaining diverse groups of women. The second phase involved a 15-minute interview, which was administered to women who met certain criteria.
Subsequently, eligible premenopausal women were enrolled from the cross-sectional phase into the longitudinal follow-up study. Enrollment into this phase began in January 1996 and all seven clinical sites completed the baseline visit by December of the following year.
The FDA highlighted that clinicians should evaluate PicoAMH Elisa test results in the context of a full clinical work up to ensure that contraceptives are not discontinued in those who have not reached menopause and that uterine bleeding due to endometrial cancer is not eliminated as a potential diagnosis. Further, 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.
There are home-use tests to assess the potential for a woman being in menopause. Unlike Ansh's offering, the home-use test kit measures follicle stimulating hormone (FSH) in the urine. FSH levels increase temporarily each month to stimulate the ovaries to produce eggs. Upon menopause, ovaries stop working and FSH levels increase. With this test, patients use their urine to react with chemicals in the test device to produce a color.