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Roche Receives Additional FDA Approval for CDx that Supports Lung Cancer Treatment

NEW YORK (GenomeWeb) – Roche announced today that the US Food and Drug Administration has approved the use of its Ventana-ALK (D5F3) assay on the Ventana BenchMark Ultra automated slide stainer.

The assay is a companion diagnostic to help in identifying ALK-positive lung cancer patients who are eligible for treatment with Pfizer's FDA-approved therapy Xalkori (crizotinib). It was CE marked in 2012, and approved by the China Food and Drug Administration in 2013. In the US, it received FDA Class III approval in June 2015 for use on Ventana BenchMark XT system.

Roche noted today that the BenchMark Ultra system has an established presence in laboratories globally, and that this new approval therefore means that more non-small cell lung cancer patients may benefit from improved treatment options.

"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 [non-small cell lung carcinoma] patients who may be eligible for improved treatment options," Ann Costello, head of Roche tissue diagnostics, said in a statement.