Via direct de novo decision, the approval was granted for Elecsys AMH test, which will enable doctors to help women looking to become pregnant or struggling with infertility.

The Elecsys AMH blood test is said to produce standardized results for evaluating ovarian reserve compared to vaginal ultrasound that depends on the operator or clinic for the result.

The assay can be used on all Roche immunoassay systems for low, mid and high volume testing environments, including cobas e 411, cobas e 601, cobas e 602 and Modular Analytics E170 analyzers.

Currently, the firm provides a range of fertility assays that process in 18 minutes, helping clinicians to assess patients quickly.

According to Roche, Anti-Müllerian hormone is exclusively produced by granulosa cells of ovarian follicles during the early stages of follicle development.

Roche has also secured FDA 510(k) clearance for its cobas c 513 analyzer and Tina-quant HbA1c Gen. 3 assay to help in testing of people with diabetes.

Roche Diagnostics chief medical officer Dr Alan Wright said: "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, faster.

"With over 7.4 million women in the U.S. who have ever used fertility services and 1 in 8 couples having trouble getting or sustaining pregnancy, the need for a consistent, reproducible and robust fertility measurement for women has never been greater."

Image: Roche Diagnostics North American headquarters in Indianapolis. Photo: courtesy of PRNewsFoto / Roche.