FDA Grants Clearance to Roche’s Anti-Mullerian Hormone Test Elecsys

The FDA cleared Roche’s anti-mullerian hormone (AMH) assay Elecsys for use in the assessment of ovarian reserve.

The fully-automated device measures the AMH levels in blood samples to assess reproductive potential based on the quality and quantity of egg cells in the ovaries. The fertility test is a standardized approach for evaluating ovarian reserve compared to other options, such as vaginal ultrasound.

Roche secured a CE mark to sell the device in all countries accepting the approval, including European, Middle Eastern and Latina American nations.