FDA Grants Ansh Labs a De Novo Clearance for the MenoCheck® Blood Test as an Aid in the Determination of Menopausal Status in Women
Ansh Labs announced today that it received clearance from U.S. Food and Drug Administration (FDA) for the de novo application of its Anti-Müllerian (AMH) assay kit, picoAMH, which is sold under the trademark MenoCheck®.
The assay kit is intended for use as an aid in the determination of menopausal status in women between 42 and 62 years of age. This is the first approved AMH test with the sensitivity to quantify declining AMH concentrations in women who are entering their menopausal transition.
Blood levels of AMH have been shown to be highly correlated with the number of primordial follicles in an ovary (i.e., the true ovarian reserve). The number of follicles declines with age, and the natural cause of menopause is the absence of these follicles. MenoCheck was developed to achieve extremely sensitive measurements of AMH providing a significant new parameter to aid physicians in determining the status of women during the menopausal transition.
Presently, menopause is determined retrospectively, since it is clinically defined by the absence of a menstrual cycle (i.e., 12 months of amenorrhea). The duration and intensity of physiological changes or vasomotor symptoms is highly variable among women during the menopausal transition. Determining where a woman is in this process is clinically important.
A sensitive AMH test result will help physicians to understand the symptoms the patient is experiencing and to select an appropriate treatment to ameliorate those symptoms and prevent complications associated with the onset of menopause. For example, determining the onset of menopause at an early age may indicate to the physician the need to investigate the potential for accelerated bone loss leading to osteoporosis. This is a significant health issue in post-menopausal women.
More objective and accurate determination of a woman’s menopausal status will help to improve the effectiveness of interventions currently implemented only after a clinical diagnosis of menopause.
The new picoAMH ELISA device uses well-established chemical principles, methodology, and components for the quantitative determination of AMH in human serum. The specificity of the antibodies, recombinant human AMH used for calibrators, and the enhanced sensitivity of the picoAMH ELISA are advantageous for the intended use of the device as an aid in the determination of menopausal status.
Ansh Labs was founded in 2011. The company is headquartered in Webster, TX. The experienced management and development teams are the leading developers and manufacturers of reproductive endocrine immunoassay test kits that are used around the world. The company is narrowly focused on women’s health in reproduction, pregnancy and cardiometabolic health. More information about Ansh Labs products and services can be found at www.anshlabs.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181031005110/en/