Roche gains FDA approval for hormone test

Roche has received clearance from the US Food and Drug Administration (FDA) for the use of its Anti-Müllerian hormone (AMH) assay.

This the first approved fully automated AMH test available for doctors looking to help women who are planning to become pregnant or struggling with infertility.

It consists of a simple blood test and can be completed in just 18 minutes, allowing clinicians to evaluate patients quickly during an office appointment.

AMH is produced by granulosa cells of ovarian follicles during the early stages of follicle development. After initially increasing until early adulthood, levels of the hormone slowly decrease with age, becoming undetectable around the menopause.

Dr Alan Wright, chief medical officer at Roche Diagnostics Corporation, said the test will ensure women can get answers about their fertility faster.

"With over 7.4 million women in the US who have ever used fertility services and one in eight couples having trouble getting or sustaining pregnancy, the need for a consistent, reproducible and robust fertility measurement for women has never been greater," he said.

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