Roche announced that it received clearance from U.S. Food and Drug Administration (FDA) via Direct de novo decision on their Anti-Müllerian (AMH) assay, making it the first approved fully automated AMH test available in the US to doctors looking to help women who are planning to become pregnant or struggling with infertility. With a simple blood test, measurement of serum AMH may now be used for the clinical assessment of 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. The assay is designed for use on all Roche immunoassay systems for low-, mid- and high-volume testing environments, including the cobas e 411, cobas e 601, cobas e 602 and MODULARANALYTICS E170 analyzers. Roche currently offers an extensive menu of fertility assays that process in 18 minutes, allowing clinicians to evaluate patients quickly during their office visit.