Roche Diagnostics launches first in vitro diagnostic ROS1 immunohistochemistry assay

Roche Diagnostics today announced the launch of the VENTANA ROS1 (SP384) Antibody, the first and only in vitro diagnostic ROS1 immunohistochemistry (IHC) assay. The test detects the presence of ROS1 protein in tissue, and may be useful in identifying ROS1-positive lung cancer cases.

Mutations of the ROS1 gene are present in some NSCLC cases and can help indicate which patients would respond with a targeted treatment.

As these types of cancer are rare, found in up to two percent 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 (NGS).

Our highly sensitive ROS1 test is the first in vitro diagnostic test available for recommended lung cancer testing guidelines, with the added benefit of rapid turnaround time. 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.”

Pierre Hazlewood, Marketing Director at Roche Diagnostics

The VENTANA ROS1 (SP384) Antibody is a CE in vitro diagnostic device and is available for use on Roche's BenchMark series of automated staining instruments.