Insight Genetics received a $1.5 million Phase II SBIR contract from the National Cancer Institute (NCI), a continuation of a $193,000 Phase I contract NCI awarded to the company back in October of 2011. The firm says this new contract will allow it to continue developing Insight ALK Resistance™, a diagnostic test that it says can help clinicians monitor non-small-cell lung cancer (NSCLC) patients for resistance to the therapies prescribed to them.
Insight ALK Resistance, according to Insight Genetics, is a qPCR-based test that that can detect all clinically identified resistance mutations in the ALK kinase domain or specific mutations within 48 hours. The test can be used for investigational research, aid in clinical decision-making for alternative treatments, help to monitor treatment efficacy, and other applications. Insight Genetics says it has obtained an exclusive worldwide license from St. Jude Children’s Research Hospital for the detection of ALK inhibitor resistance mutations.
The firm adds that this SBIR award, its sixth contract and third consecutive Phase II contract from NCI’s Companion Diagnostics program, will allow it to refine the assay further toward a premarket approval application with the FDA.
"The Insight ALK Resistance assay meets a significant unmet need in non-small-cell lung cancer by giving physicians a way to monitor their patients for drug resistance and providing information to help them determine the most effective course of treatment," Eric Dahlhauser, chairman and CEO of Insight Genetics, said in a statement. "Our team is delighted to continue our collaboration with the NCI to create companion diagnostic tests that can enhance how cancer is diagnosed, treated and monitored."