First ever FDA cleared, clinically validated blood test to help physicians assess a woman’s menopausal status. By measuring ultra-low levels of Anti-Müllerian Hormone (AMH), the test provides estimates of the time to final menstrual period, thus facilitating better preventive care for symptoms that disrupt everyday quality of life and to reduce the risk of diseases and conditions associated with loss of ovarian hormones.
MenoCheck is the only commercially available AMH immunoassay that has the sensitivity to detect ultra-low levels of AMH in menopausal women. The data supporting the use of the MenoCheck test was acquired from over 1500 women participating in a 20-year study, involving careful clinical observations and hormone measurements annually, as they underwent the menopausal transition and 12 months of amenorrhea to allow an accurate FMP date.
AMH Values and Time to Final Menstrual Period
The FMP for each woman in the SWAN Study were assigned retrospectively after 12 months of amenorrhea (the clinical definition of natural menopause). Menopausal categories for assigning status were based on the approximate time to the FMP. Three menopausal categories were defined based on the time to final menstrual period (TTFMP).
|Category||Menopausal Category||MenoCheck (pg/mL)|
|High||> 5 years from FMP||≥100 pg/mL|
|Medium||< 5 years from FMP||10-99.9 pg/mL|
|Low||at FMP or later||≤10 pg/mL|
NOTE: AMH values are not commutable between brands. And, AMH results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings when being interpreted for diagnostic purposes.