Roche announces FDA approval of companion diagnostic to identify ALK-positive non-small cell lung cancer patients

On Jun 1, 2017

Roche announced US Food and Drug Administration (FDA) approval of the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Novartis drug ZYKADIA (ceritinib). The VENTANA ALK (D5F3) Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for ZYKADIA.

Non-small cell lung cancer tissue stained with the VENTANA ALK (D5F3) CDx Assay and OptiView DAB Detection and Amplification (Source: Roche)

Lung cancer remains the leading cause of cancer deaths, with more than 1.6 million deaths worldwide each year.

“With the FDA’s approval of the expanded use of the VENTANA ALK (D5F3) CDx Assay to determine which lung cancer patients are eligible for ZYKADIA, we are helping clinicians and their patients identify additional treatment options for non-small cell lung cancer,” said Ann Costello, Head of Roche Tissue Diagnostics. “This is another example of Roche’s continued commitment to advancing the standard of care for lung cancer patients and personalized medicine.”

The VENTANA ALK (D5F3) CDx Assay is available for use on BenchMark IHC/ISH instruments.

About the VENTANA ALK (D5F3) CDx Assay
VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI (crizotinib) or ZYKADIA (ceritinib).

This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls.

This product is intended for in vitro diagnostic (IVD) use.