Beckman Coulter Diagnostics announced FDA clearance of its automated Access AMH immunoassay

Laboratories in the U.S. are now able to perform reproductive testing using the automated Anti-Müllerian Hormone (AMH) assay with the Access 2 or DxI Immunoassay systems

BREA, Calif. — (Dec. 21, 2017) — Beckman Coulter Diagnostics announced FDA clearance of its automated Access AMH immunoassay for in vitro diagnostic (IVD) use in the U.S. 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.

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 AMH assays have been studied extensively and have played an important role in establishing the acceptance of AMH testing in the field of fertility. Because Beckman Coulter is the most experienced market innovator—having developed the first ELISA AMH assay and the first automated AMH tests—healthcare providers can feel confident in the results they receive from the company's reproductive health products. Further, clinicians find greater assurance in the understanding that Beckman Coulter's AMH antibody is used in all automated AMH assays available in the U.S. today and that Beckman Coulter 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 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," said Clarisa R. Gracia, M.D., director of fertility preservation, associate professor of obstetrics and gynecology, the Hospital of the University of Pennsylvania.

The only automated AMH immunoassay to use a recombinant human antigen, the Access AMH assay gives patients and healthcare providers consistent and dependable results. It is part of a scalable immunoassay solution that includes the Access 2 and UniCel DxI systems and a leading reproductive menu offering.

About Beckman Coulter

Beckman Coulter Diagnostics helps healthcare and laboratory professionals provide better patient care by delivering the accurate diagnostic information they need, when they need it. For over 80 years, Beckman Coulter has been the partner of choice for healthcare organizations. Our scalable instruments, comprehensive diagnostic tests and business management services are trusted by hospitals, laboratories and other critical care settings around the world. We share in our customers' mission toward continuous improvement and quality patient care because we believe when efficiency and clinical outcomes are improved, patients benefit and we can move healthcare forward for every person.

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