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Beckman Coulter Gets FDA Clearance for Fertility Assay

NEW YORK (360Dx) – Beckman Coulter Diagnostics said today that it has received US Food and Drug Administration clearance for its automated Access AMH test, a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone levels.

Beckman noted that the anti-Müllerian hormone 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.

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 said.

The Access AMH assay is intended for use in conjunction with other clinical and laboratory findings, such as antral follicle count, before starting fertility therapy, the firm added.

Clarisa Gracia, director of fertility preservation and associate professor of obstetrics and gynecology at the Hospital of the University of Pennsylvania, said in a statement that the Access AMH assay was FDA cleared for clinical use after a rigorous multi-center study.

Beckman said that it is the only automated AMH immunoassay to use a recombinant human antigen and that the assay is part of a scalable immunoassay solution that includes the firm's Access 2 and UniCel DxI systems.

The firm noted that its AMH antibody is used in all automated AMH assays available in the US today, adding that it controls exclusive rights to AMH antibodies for Müllerian-inhibiting substance levels and ovarian response.