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.”

Lung cancer causes more than three deaths every minute, and is the most common cancer worldwide. Each year, an estimated 2.1 million people are diagnosed. It is divided into two main subtypes, non-small cell lung cancer and small cell lung cancer. Up to 85% of all lung cancers are NSCLC, which can be further subtyped into adenocarcinoma, squamous cell carcinoma and large cell carcinoma.

The need for accurate classification of these subtypes has been amplified with the introduction of targeted therapies, which have shifted the lung cancer treatment paradigm away from being based only on histological subtype, to incorporating subtyping involving oncogenic mutations and fusions.