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# FDA Allows Roche to Market Anti-Müllerian Assay
- URL: https://www.fdaweb.com/fda-allows-roche-to-market-anti-mullerian-assay/
- Published: 2017-01-06T12:00:00.000Z
- Updated: 2026-09-14T21:58:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137656

FDA has granted a Roche *de novo* request to allow the marketing of its Anti-Müllerian (AMH) assay, what the company calls the first approved fully automated AMH test available in the U.S. to help women who are planning to become pregnant or struggling with infertility. The blood test is intended to measure serum AMH to assess ovarian reserve. “The Elecsys AMH blood test produces standardized results for assessing ovarian reserve as compared with the use of vaginal ultrasound in which the result is often dependent on the operator or clinic,” Roche says.