The FDA approved the test last month.
Women who want to know if they have entered menopause — or when they will — may be able to find out with a new blood test.
The U.S. Food and Drug Administration (FDA) recently granted approval to the PicoAMH Elisa test. It’s produced by Ansh Labs.
The test works by measuring anti-Müllerian hormone (AMH), which is a marker of ovarian function. It’s supposed to be used with other clinical evaluations and laboratory findings to give physicians a better idea of a woman’s menopausal status.
The test was evaluated using data from 690 women between the ages of 42 and 62. Results showed that it performed “reasonably well” at detecting AMH levels. It also was able to pinpoint if a woman had experienced her last menstrual period, and if she was more than five years away from it.
“Diagnostic results about a woman’s menopausal status may prompt discussions about preventative care for women experiencing menopausal symptoms,” said Courtney Lias, PhD, director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health. She said the test can give doctors more information to discuss preventative care with patients. For example, it could help them gauge where a woman is, as far as menopause status, so they can prevent bone mineral density loss or cardiovascular disease. The risks of those are known to increase after menopause.
The FDA said that clinicians should evaluate the results of the test in the context of a full clinical workup to ensure 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. It shouldn’t be used as a fertility-related tool, the FDA added.
As it stands, there are several ways that a doctor can gauge whether or not a woman is in menopause. A vaginal swab can be used to evaluate pH levels. Blood tests to measure follicle-stimulating hormone (FSH) and estrogen have also been used.
Dr. Mary Ellen Pavone, associate professor of obstetrics and gynecology at Northwestern University Feinberg School of Medicine, explained that AMH is the first value to drop as women approach menopause. Menopause is “always a retrospective clinical diagnosis” that is defined as not having a period for at least one year. It’s not a lab diagnosis, she added.
“Although this test may suggest menopause or that someone may be entering menopause soon, it cannot substitute for a clinical diagnosis,” Pavone said.
Periods can become irregular leading up to menopause, so the test may give doctors a better idea of a woman’s menopause status.
When women begin to miss more than three periods in a row or have fewer than nine per year (and that is a change for them), it can suggest that a woman is entering menopause early, added Dr. JoAnn Pinkerton, executive director of The North American Menopause Society (NAMS), who is also a professor with the University of Virginia Health System.
Pinkerton said the new test referenced in the study could be useful to help women get a better idea of when they may enter menopause, and offer trustworthy, consistent results.
The new test may be quite valuable to women who show symptoms of perimenopause, which can also have adverse health impacts. Perimenopause is when the ovaries start to make less estrogen in the period before menopause begins.
Early menopause is associated with a higher risk of osteoporosis and fracture, heart disease, cognitive changes, vaginal changes and loss of libido, and mood changes.
It could also assist doctors in treating patients with premature menopause or premature ovarian failure (POF) — also known as primary ovarian insufficiency (POI). This happens when a woman experiences menopause prior to turning age 40, and these women may have normal FSH.
Blood tests currently used to give insight into perimenopause timing do not offer reliable results, especially when women are using oral contraceptives or using hormone therapy, she noted.
“Women with abnormal AMH suggestive of higher risk of menopause need to be informed that menopause may occur early. That includes discussion of decreased fertility as well as typical menopausal symptoms and health risks,” she said.
A new test approved by the FDA can help women determine if they are experiencing menopause.
The new test may be helpful to women who show symptoms of perimenopause, which can also have adverse health impacts. Early menopause is associated with a higher risk of osteoporosis and fracture, heart disease, cognitive changes, vaginal changes and loss of libido, and mood changes.