Beckman Coulter Diagnostics, Brea, Calif, has received FDA premarket notification (510(k)) clearance of its automated Access anti-Müllerian hormone (AMH) immunoassay for in vitro diagnostic use in the United States. The 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.
According to Beckman Coulter, advancing maternal age and the associated decline in egg quality and quantity have led to the need for fast, accurate ovarian reserve assessment for women. Beckman Coulter’s AMH antibody is used in all automated AMH assays available in the United States, and the company controls exclusive rights to AMH antibodies for Müllerian-inhibiting substance levels and ovarian response.
The Access AMH assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of AMH levels. Results can be used as an aid in the assessment of ovarian reserve in women presenting to fertility clinics. The test is intended for use in conjunction with other clinical and laboratory findings, such as antral follicle count, before starting fertility therapy.
“The AMH assay is a valuable test that we have incorporated at our fertility clinic in order to assess ovarian reserve,” says Clarisa R. Gracia, MD, director of fertility preservation and associate professor of obstetrics and gynecology at the Hospital of the University of Pennsylvania. “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 only automated AMH immunoassay to use a recombinant human antigen, the Access AMH assay is part of a scalable immunoassay system that includes the Access 2 and UniCel DxI systems.
For more information, visit Beckman Coulter Diagnostics.