Beckman Coulter Wins FDA Clearance for Access AMH Immunoassay

December 26, 2017
Beckman Coulter Wins FDA Clearance for Access AMH Immunoassay
Beckman Coulter Diagnostics has won FDA clearance for its automated Access AMH fertililty immunoassay, designed for quantitative measure of anti-Müllerian hormone (AMH) levels. [Source: Beckman Coulter Diagnostics]

Beckman Coulter Diagnostics has won FDA clearance for its automated Access AMH immunoassay for in vitro diagnostic (IVD) use in the U.S.

The Access AMH assay is a paramagnetic particle chemiluminescent immunoassay that is designed for quantitative determination of anti-Müllerian hormone (AMH) levels. Access AMH is designed to aid healthcare providers in assessing a woman's ovarian reserve, as well as help guide the clinical management of women struggling with infertility or planning to become pregnant later in life.

Access AMH is the only automated AMH immunoassay to use a recombinant human antigen—resulting in consistent and dependable results for patients and healthcare providers, according to Beckman Coulter.  

The test is part of a scalable immunoassay solution that includes the Access 2 and UniCel DxI immunoassay systems and a reproductive menu offering. Access AMH is intended for use in conjunction with other clinical and laboratory findings, such as antral follicle count, before starting fertility therapy.

Beckman Coulter says Access AMH offers several advantages over manual assays, including:

  • 16x increase in sensitivity and expand low-end sensitivity to a proven 0.0049 ng/mL limit of detection
  • 16% reduction in testing costs
  • 80% reduction in technologist handling time, allowing for greater walkaway time through random access capabilities and once-a-month system calibration
  • 4x quicker Thrombin-antithrombin (TAT)—40 minutes with an automated assay compared with 170 minutes with ELISA
  • increased physician and patient confidence with a recombinant human AMH calibrator designed for greater stability and accuracy in mirroring AMH in patient samples for greater immunological recognition of antibodies.

In a statement, Beckman Coulter noted that it developed the first ELISA AMH assay and first automated AMH tests; that it controls exclusive rights to AMH antibodies for Müllerian Inhibiting Substance Levels and Ovarian Response; and that its AMH antibody is used in all automated AMH assays available in the U.S.

“The Access AMH assay is a new automated AMH assay which has recently been FDA cleared for clinical use after a rigorous multicenter study. I anticipate that this automated platform will make this assay more widely available,” Clarisa R. Gracia, M.D., director of fertility preservation, associate professor of obstetrics and gynecology, the Hospital of the University of Pennsylvania, said in Beckman Coulter’s December 21 statement.