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Beckman Coulter’s FDA-Cleared In Vitro Diagnostic to Improve Fertility Testing

The FDA has approved an automated Access Anti-Müllerian Hormone (AMH) assay developed by Beckman Coulter Diagnostics to help healthcare providers guide their patients through decisions regarding fertility.

Beckman Coulter’s FDA-Cleared In Vitro Diagnostic to Improve Fertility Testing

By: Sarah Hand, M.Sc.

Posted on: in News | Medical Device Diagnostics News | Medical Device News | Medical Device Safety and Regulation News

As a woman’s maternal age advances, the need to accurately assess her ovarian reserve becomes more important. Now, the FDA has approved an automated Access Anti-Müllerian Hormone (AMH) assay developed by Beckman Coulter Diagnostics to help healthcare providers guide their patients through decisions regarding fertility.

“The Anti-Müllerian Hormone assay is a valuable test that we have incorporated at our fertility clinic in order to assess ovarian reserve,” said Dr. Clarisa R. Gracia, director of fertility preservation, associate professor of obstetrics and gynecology, 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. I anticipate that this automated platform will make this assay more widely available.”

As a paramagnetic particle chemiluminescent immunoassay, the Access AMH assay quantitatively detects AMH levels. In conjunction with other laboratory tests, the Access AMH assay can help assess ovarian reserve and inform treatment decisions for infertility.

Beckman Coulter was the first diagnostics company to develop an ELISA-based AMH assay, the study of which has helped to establish AMH testing as an accurate measure of fertility. The Access AMH assay is designed to be run on the Access 2 and UniCel DxI systems for fast and accurate results reporting.

Between 2011 and 2015, just over 12 percent of women aged 15 to 44 in the US had some type of infertility, according to the CDC. According to a July 2017 article published in The New York Times, the US fertility rate in 2016 hit a record low, however women over the age of 40 saw increased fertility suggesting that reproductive technologies may be benefiting this age group.


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