Insight Genetics has received a Phase II SBIR contract from the National Cancer Institute (NCI) to continue its development of a diagnostic test that meets the significant unmet need for the diagnosis and treatment of non-small cell lung cancer (NSCLC). A continuation of work that Insight Genetics began with the NCI in 2012, the US$1,499,412 fast-track contract will advance the development of a panel of assays designed to provide a fast and accurate way to identify and characterise oncogenic ROS1, RET and DEPDC1 in a population of NSCLC patients who are triple negative for mutations in EGFr, KRAS, or ALK.
As part of its Phase II contract, Insight Genetics will continue analytical and clinical validation of its three real-time qPCR-based NSCLC assays: Insight ROS Screen, Insight RET Screen, and Insight DEPDC1 Screen. Initial experiments have demonstrated that these proprietary tests are highly sensitive and specific, offering results within 24 hours. This is a significant contrast to fluorescence in situ hybridisation detection assays for ROS1 and RETS, which are costly, typically less sensitive, and take between three to seven days to provide results.
This SBIR award is Insight Genetics' fifth contract and second consecutive Phase II contract from NCI's companion diagnostics programme.