FDA Oks Roche' VENTANA ALK CDx Assay For Use On VENTANA BenchMark ULTRA System

(RTTNews) - Roche (RHHBY) announced that the U.S. Food and Drug Administration or FDA has approved the VENTANA ALK or D5F3 CDx Assay for use on the VENTANA BenchMark ULTRA automated slide stainer. The assay is a companion diagnostic to aid in the identification of ALK-positive lung cancer patients who are eligible for treatment with Pfizer's FDA-approved therapy XALKORI (crizotinib).

The VENTANA ALK (D5F3) CDx Assay was approved in 2012 in countries accepting the CE mark and by the China Food and Drug Administration (CFDA) in 2013. It received FDA Class III approval in June 2015 for use on VENTANA BenchMark XT system. Due to an established presence of the BenchMark ULTRA system in laboratories globally, this latest approval means even more non-small cell lung cancer (NSCLC) patients may benefit from improved treatment options.