Roche gets FDA clearance for AMH assay for ovarian reserve assessment
Roche has secured the US Food and Drug Administration (FDA) approval for its Anti-Müllerian hormone (AMH) assay to assist women planning for pregnancy and address infertility in women.
The Elecsys AMH blood test is a simple blood test which measures serum AMH, which is used for the clinical assessment of ovarian reserve.
AMH is produced by granulosa cells of ovarian follicles during its early stages of development.
AMH concentrations tend to gradually decrease with an advancing age until it becomes undetectable before menopause following an initial increase till early adulthood in a woman.
Individual AMH serum concentration gives an accurate information on the size of the pool of antral follicles, representing the quantity of the remaining primordial follicles.
Unlike the assessment of ovarian reserve using vaginal ultrasound, the AMH blood test generates results independent of the operator or the clinic.
The assay can be used 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 MODULAR ANALYTICS E170 analyzers.
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 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."
Currently, Roche offers a range of fertility assays that process in 18 minutes enabling a quick evaluation of patients.
Image: Roche Diagnostics North American headquarters. Photo: courtesy of Roche Diagnostics Corporation.