FDA Approves Roche's Ventana ALK (D5F3) CDx Assay

November 8, 2016

The FDA has granted approval to the Ventana ALK (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 (anaplastic lymphoma kinase) ALK-positive lung cancer patients who are eligible for treatment with Pfizer's FDA-approved therapy Xalkori.

“ALK is a biomarker found in non-small cell lung cancer. Detection and inhibition of this biomarker can help shrink tumors in some ALK-positive patients," the company said. — Cynthia Jessup

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