Roche launches first in vitro lung cancer diagnostic test
pharmatimes | June 10, 2019
Roche Diagnostics has launched its first in vitro diagnostic test to target ROS1 positive lung cancers, VENTANA ROS1 (SP384) Antibody. The biomarker is the first and only in vitro diagnostic ROS1 immunohistochemistry assay on the market and looks promising to provide a cost-effective and efficient means to initially identify the presence of elevated ROS1 protein expression in cancer. Mutations of the ROS1 gene are present in some non-small cell lung cancer (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 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 hybridisation (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,” said Pierre Hazlewood, marketing director at Roche Diagnostics. He continued, “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.”