Roche gets FDA approval for VENTANA ALK (D5F3) CDx Assay

9 November 2016 (Last Updated November 9th, 2016 18:30)

Roche has secured the US Food and Drug Administration (FDA) approval for its VENTANA ALK (D5F3) CDx Assay to be used on the VENTANA BenchMark ULTRA automated slide stainer.

Roche has secured the US Food and Drug Administration (FDA) approval for its VENTANA ALK (D5F3) CDx Assay to be used on the VENTANA BenchMark ULTRA automated slide stainer.

The latest approval will expand the usage of the companion diagnostic assay in identifying ALK-positive lung cancer patients who will be eligible to be administered with Pfizer's FDA-approved therapy XALKORI.

Roche Tissue Diagnostics head Ann Costello said: "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.

"Detection and inhibition of this biomarker can help shrink tumors in some ALK-positive patients."

"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."

Intended for laboratory use, the VENTANA ALK (D5F3) CDx Assay can detect the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with the VENTANA BenchMark XT and VENTANA BenchMark ULTRA immunohistochemical (IHC) automated slide stainers.

The BenchMark ULTRA platform offers fully integrated staining solution through continuous and random processing of up to 90 slides in eight hours, or 120 slides with an overnight run.


Image: VENTANA BenchMark ULTRA IHC/ISH staining instrument. Photo: courtesy of Ventana Medical Systems, Inc.