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Roche Gets FDA Approval for Ovarian Reserve Assay

NEW YORK (360Dx) – Roche announced late Friday that it has received US Food and Drug Administration clearance for its Elecsys Anti-Müllerian hormone (AMH) assay.

According to the company, the assay is the first approved fully automated AMH test available in the US. Roche said that the assay was approved via the FDA's de novo classification option.

AMH is a protein expressed by granulosa cells in ovarian follicles and is used as a biomarker in assessing a woman's ovarian reserve. The Elecsys assay is designed to measure AMH levels from a blood sample and runs on all of Roche's immunoassay systems.

"Our new assay will help more doctors incorporate AMH testing into their routine clinical practice, ensuring that more women who have questions about their fertility can get answers," Alan Wright, chief medical officer for Roche Diagnostics, said in a statement.