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Roche gets FDA approval for Ventana ALK CDx assay to identify lung cancer patients eligible for treatment with Alecensa

Published 08 November 2017

Roche has obtained US Food and Drug Administration (FDA) approval for 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 Roche medicine ALECENSA (alectinib).

The Ventana ALK (D5F3) CDx Assay is the only test FDA-approved as a companion diagnostic for ALECENSA.

"We are very excited about the companion diagnostic label expansion for the ALK (D5F3) assay. This immunohistochemistry assay will deliver critical information on treatment options for non-small cell lung cancer patients," said Ann Costello, Head of Roche Tissue Diagnostics.

"The ability to identify ALK-positive patients very quickly with a simple IHC test ensures that more patients can benefit from targeted therapy."

The VENTANA ALK (D5F3) CDx Assay has been shown in studies to identify more patients that will benefit from an anti-ALK target therapy than fluorescent in situ hybridization (FISH) testing.3,4,5,6 The VENTANA ALK (D5F3) CDx Assay is available for use on the Roche BenchMark XT or BenchMark ULTRA IHC/ISH slide staining systems.7 

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), ZYKADIA® (ceritinib) or ALECENSA® (alectinib).

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



Source: Company Press Release