Roche launches first in vitro diagnostic IHC test to detect ROS1 protein in cancers

Roche has announced the global launch of the VENTANA ROS1 (SP384) rabbit monoclonal primary antibody, the first and only in vitro diagnostic ROS1 immunohistochemistry (IHC) assay. The test is designed to detect the presence of ROS1 protein in tissue, and may be useful in identifying ROS1-positive cancer cases. Guidelines from the College of American Pathologists and the National Comprehensive Cancer Network recommend ROS1 testing for confirmed lung adenocarcinoma cases.

As these types of cancer are rare, found in up to 2% of non-small cell lung cancer cases, the use of a ROS1 IHC biomarker may provide a cost-effective and efficient means of identifying cases with elevated ROS1 protein expression before confirming by another method, such as by fluorescence in situ hybridization (FISH) or next-generation sequencing.

“Our highly sensitive ROS1 test is the first in vitro diagnostic IHC available for recommended lung cancer testing guidelines, with the added benefit of rapid turnaround time," said Jill German, Head of Roche Tissue Diagnostics. “While this is important in non-small cell lung cancer cases today, ROS1 is also being investigated in a number of clinical trials in other cancer types.”

The VENTANA ROS1 (SP384) rabbit monoclonal primary antibody is a US class I/CE in vitro diagnostic device and is available for use on Roche’s BenchMark series of automated staining instruments.

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