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Roche’s Ventana ALK (D5F3) CDx assay wins FDA approval for use on BenchMark Ultra system

MDBR Staff Writer Published 09 November 2016

Roche has secured approval from the US Food and Drug Administration (FDA) to use Ventana ALK (D5F3) CDx assay on Ventana BenchMark Ultra automated slide stainer.

The assay has been defor laboratory use in the detection of 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 strainers.

The companion diagnostic test will identify ALK-positive lung cancer patients who are eligible for treatment with Pfizer's FDA-approved therapy Xalkori  (crizotinib).

Ventana ALK CDx assay secured CE mark approval in 2012, while from the China Food and Drug Administration (CFDA) in 2013. It obtained FDA Class III approval for use on BenchMark XT system in June 2015.

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.

"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."

In October, Roche secured FDA approval for its fully automated blood screening assay for use on the cobas 6800 and 8800 systems.

The donor screening laboratories can use the cobas MPX test to apply an advanced PCR-based diagnostic technology to the surveillance of donated blood and plasma in the US.


Image:Ventana BenchMark Ultra IHC/ISH staining instrument. Photo: courtsy of PRNewsFoto/Roche.