Roche Submits Anti-Mullerian Hormone Assay For FDA Approval - QUick Facts

(RTTNews) - Swiss pharmaceutical giant Roche Holding AG (RHHBY) said it has filed a direct de novo application to the U.S. Food and Drug Administration for a fully automated Anti-Mullerian or AMH assay for use on Roche's full portfolio of laboratory analyzers.

The company noted that the determination of AMH is useful for the assessment of ovarian reserve in women presenting to infertility clinics for evaluation in conjunction with other clinical and laboratory findings.

Dr. Alan Wright, Chief Medical Officer of Roche Diagnostics Corp said, "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 standardized, reproducible and robust fertility measurement for women has never been greater."

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.