Beckman Coulter recently announced that it received FDA clearance for its automated Access AMH test, a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels. This simple test aids healthcare providers in the assessment of a woman's ovarian reserve, and helps guide the clinical management of women struggling with infertility or planning to become pregnant later in life. This assay is designed for use in conjunction with other clinical and laboratory findings such as antral follicle count, before starting fertility therapy.
The only automated AMH immunoassay to use a recombinant human antigen, the Access AMH assay gives patients and healthcare providers consistent and dependable results. Clinical laboratories in the U.S. can now perform reproductive testing using the automated Anti-Müllerian Hormone (AMH) assay with the Access 2 or DxI Immunoassay systems.
The Access AMH assay has been incorporated at the fertility clinic of the Hospital of the University of Pennsylvania. The Beckman Coulter press release announcing FDA clearance for the assay cites Clarisa R. Gracia, M.D., director of fertility preservation, associate professor of obstetrics and gynecology, the Hospital of the University of Pennsylvania, as saying, "The Anti-Müllerian Hormone assay is a valuable test that we have incorporated at our fertility clinic in order to assess ovarian reserve. Measures of ovarian reserve such as AMH and antral follicle counts are helpful to predict an infertile woman's response to controlled ovarian stimulation. The Access AMH assay is a new automated AMH assay which has recently been FDA cleared for clinical use after a rigorous multi-center study. I anticipate that this automated platform will make this assay more widely available."
By helping in the assessment of a woman's ovarian reserve, the assay helps guide the clinical management of women struggling with infertility or planning to become pregnant later in life. Test results can be used as an aid in the assessment of ovarian reserve in women presenting to fertility clinics.