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MDx/CDx Focus: Ventana IHC BRAF Test; Myriad Files IDE for BRACAnalysis in Phase III BioMarin Trial

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Ventana Launches First IHC BRAF Mutation Test

Ventana Medical Systems, a Roche subsidiary, this week launched an immunohistochemistry test for gauging the BRAF V600E mutation in different tumor types.

The company claims this is the first such commercially available test on the market. Roche also markets a real-time PCR based companion diagnostic on the Cobas platform for assessing BRAF mutations in melanoma patients considering treatment with its BRAF inhibitor Zelboraf (vemurafenib).

"The new Ventana IHC BRAF assay expands Roche's offering in BRAF V600E testing into disease areas beyond melanoma," the company said in a statement.

V600E is the most common BRAF mutation and is associated with a number of cancers, including colorectal cancer, papillary thyroid cancer, and hairy cell leukemia.

Ventana has an exclusive licensing agreement with the German Cancer Research Center and the University Hospital Heidelberg to commercialize the IHC primary antibody that detects the mutated BRAF V600E protein.

The Ventana BRAF V600E Mouse Monoclonal Primary Antibody IHC assay can be performed on all of Ventana's Benchmark IHC platforms, using the OptiView DAB IHC Detection Kit.


BioMarin Using Myriad's BRACAnalysis in Phase III Study for BMN-673

BioMarin will use Myriad Genetics' BRACAnalysis test to determine best responders to its investigational PARP inhibitor BMN-673 in Phase III studies involving breast cancer patients with BRCA-mutated tumors.

In preparation for this, Myriad has submitted for an investigational device exemption with the US Food and Drug Administration, allowing the company to use BRACAnalysis as part of human trials.

In a statement, Len Post, BioMarin's chief scientific officer, said that the company worked with Myriad to use BRACAnalysis in a Phase I study involving BMN-673 in solid tumors. "Identifying the right patients to enroll in our Phase III study for BMN-673 in BRCA breast cancer will be critical in answering important scientific questions about the safety and efficacy of the compound in this select population," Post said.

BMN-673 inhibits PARP proteins from repairing DNA breaks in cells. Since patients with BRCA mutations already have an impaired ability to repair DNA, researchers are hoping that when given a PARP inhibitor, patients' cancer cells will be inundated with damaged DNA and die.

Myriad and BioMarin did not disclose additional terms of their companion diagnostics deal.

Earlier this year, Myriad inked a similar companion diagnostic deal with AstraZeneca to stratify patients in clinical trials involving the PARP inhibitor olaparib (PGx Reporter 6/5/2013). Tesaro is initiating two Phase III trials for its PARP inhibitor using BRACAnalysis to stratify patients. Cephalon and AbbVie are also using Myriad's test in earlier stage trials for their PARP inhibitor programs.

The Scan

Genome Sequences Reveal Range Mutations in Induced Pluripotent Stem Cells

Researchers in Nature Genetics detect somatic mutation variation across iPSCs generated from blood or skin fibroblast cell sources, along with selection for BCOR gene mutations.

Researchers Reprogram Plant Roots With Synthetic Genetic Circuit Strategy

Root gene expression was altered with the help of genetic circuits built around a series of synthetic transcriptional regulators in the Nicotiana benthamiana plant in a Science paper.

Infectious Disease Tracking Study Compares Genome Sequencing Approaches

Researchers in BMC Genomics see advantages for capture-based Illumina sequencing and amplicon-based sequencing on the Nanopore instrument, depending on the situation or samples available.

LINE-1 Linked to Premature Aging Conditions

Researchers report in Science Translational Medicine that the accumulation of LINE-1 RNA contributes to premature aging conditions and that symptoms can be improved by targeting them.