Roche files direct de novo application to FDA for Anti-Mullerian assay

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has filed a direct de novo application to the U.S. Food and Drug Administration (FDA) for a fully automated Anti-Mullerian (AMH) assay for use on Roche's full portfolio of laboratory analyzers. 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.

"Our Elecsys^® AMH test will help physicians incorporate AMH testing into routine clinical practice and get more reliable results even faster than conventional protocols and manual AMH assays," explained Dr. Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation. "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."

Serum levels of AMH have been shown to be relatively stable during the menstrual cycle with substantial fluctuations being observed in younger women. AMH levels further demonstrate lower intra- and inter-cyclic than baseline FSH. Measurement of serum AMH is used for the clinical assessment of ovarian reserve, an important measure for women who are either planning for pregnancy or struggling with infertility. The Elecsys^® AMH blood test produces standardized results for assessing ovarian reserve as compared with the use of ultrasound for assessing AFC in which the result is often dependent on the operator or clinic.

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 MODULAR ANALYTICS E170 analyzers.

"Once approved, this test will assist clinicians in more predictive, personalized fertility care for their patients," said Dr. Wright. "Our aim is to give healthcare providers confidence in their patient results and to give women a rapid answer (18 minutes) to a very important, deeply personal question about their fertility."

Roche currently offers an extensive menu of fertility assays that process in less than 18 minutes, allowing clinicians to evaluate patients quickly during their office visit.