Roche introduces first and only in vitro diagnostic ROS1 IHC assay

Roche has introduced Ventanna ROS1 (SP384) Rabbit Monoclonal Primary Antibody, a US class I/CE in vitro diagnostic device available for use on Roche’s BenchMark series of automated staining instruments. It is the first in vitro diagnostic immunohistochemistry test developed to detect the presence of ROS1 protein in tissue, which will help to identify cases with elevated ROS1 protein expression before confirming by another method such as fluorescence in situ hybridization or next-generation sequencing.
Jill German, head of Roche Tissue Diagnostics, said: “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. 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.”