FDA approves VENTANA ALK (D5F3) CDx Assay

Roche's VENTANA ALK (D5F3) CDx Assay has received approval from the U.S. Food and Drug Administration to be used in conjunction with the VENTANA BenchMark ULTRA automated slide stainer.
The VENTANA ALK (D5F3) CDx Assay is a diagnostic companion that is used to identify patients with ALK-positive lung cancer who are eligible to receive treatment from Pfizer’s XALKORI therapy, which has been approved by the FDA.
"ALK is an important biomarker found in non-small cell lung cancer. Detection and inhibition of this biomarker can help shrink tumors in some ALK-positive patients," Ann Costello, head of Roche Tissue Diagnostics, said. "The FDA's approval of the VENTANA ALK CDx Assay on the VENTANA BenchMark ULTRA system underscores our continued commitment to expanding the identification of NSCLC patients who may be eligible for improved treatment options."
In 2012, the VENTANA ALK (D5F3) CDx Assay was approved by countries that accept the CE mark and in 2013 by the China Food and Drug Administration (CFDA). In June 2015, the VENTANA Assay was the recipient of a Class III approval by the FDA for use on the VENTANA BenchMark XT system.