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

Roche announced today that it has filed a direct de novo application to the U.S. Food and Drug Administration 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.