Automated IHC Test Detects BRAF V600E Mutation in Cancers

The first BRAF V600E immunohistochemistry (IHC) test to detect the BRAF V600E mutation in a variety of tumors was launched.

The BRAF V600E mutation plays a key role in a variety of cancers including colorectal cancer—the third most common type of cancer and third leading cause of cancer deaths worldwide. The BRAF V600E mutation is also known to play a role in other cancers such as melanoma, papillary thyroid cancer, and hairy cell leukemia.

Ventana Medical Systems, Inc. (Ventana; Tucson, AZ, USA), a member of the Roche Group, announced the global launch of The Ventana BRAF V600E (VE1) assay. The Mouse Monoclonal Primary Antibody in vitro diagnostic antibody is being launched as a US Class I exempt/CE-IVD product.

Ventana president Mara G. Aspinall, said, "The BRAF V600E (VE1) IHC in vitro diagnostic is a valuable addition to our assay portfolio to aid physicians and patients in the important stratification of colon cancer."

The Ventana BRAF V600E (VE1) mouse monoclonal primary antibody IHC assay is the result of the company's exclusive license agreement with the German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ; Heidelberg, Germany) and the University Hospital (Heidelberg, Germany) to commercialize the novel IHC primary antibody that detects the V600E mutated BRAF protein. This fully automated IHC test provides lab professionals and pathologists with a sensitive and specific, standardized testing method for the assessment of the BRAF V600E mutation in tissue. The assay is optimized to perform on all Ventana Benchmark IHC platforms with the OptiView DAB IHC detection kit, providing easy interpretation and integration into a laboratory's workflow.

Roche also offers the cobas 4800 BRAF V600 mutation test, which is the companion diagnostic for Zelboraf (vemurafenib). This test was clinically validated to select patients in the BRIM-3 study, and only patients selected by this test were shown to benefit from Zelboraf therapy. The new Ventana IHC BRAF assay expands Roche's offering in BRAF V600E testing into disease areas beyond melanoma.

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Ventana Medical Systems
Deutsches Krebsforschungszentrum
University Hospital