Insight Genetics Inc. of Nashville, Tenn., has received a new $1.5 million Phase II Small Business Innovation Research (SBIR) contract from the National Cancer Institute (NCI). Continuing a Phase I contract awarded in 2011, the new contract will enable the company to continue developing its Insight ALK Resistance assay, a diagnostic test that helps clinicians monitor patients with non-small cell lung cancer (NSCLC) for resistance to prescribed cancer therapy.
“Resistance is a growing concern in the cancer treatment world,” said Eric Dahlhauser, chairman and CEO of Insight Genetics. “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. 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.”
Researchers have developed targeted therapeutics that effectively inhibit known genetic drivers of NSCLC, such as epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations. However, most patients develop resistance to their prescribed inhibitor within a year, making it no longer effective. Inhibitor resistance is driven by mutations in either the primary oncogenic gene or a separate gene in a secondary pool of cancer cells. Identification of the genetic driver of a patient’s inhibitor resistance can help a physician choose the appropriate ongoing treatment for the patient, which could include a next-generation inhibitor or other therapy that targets a separate oncogenic driver.
Insight ALK Resistance is a qPCR-based test that is customizable to detect all clinically identified resistance mutations in the ALK kinase domain or specific mutations, providing results within 48 hours and with a minimal tissue requirement. The test can be used for various applications, including providing guidance in monitoring treatment efficacy, clinical decision making for alternative treatments, clinical trial enrollment for next-generation ALK inhibitors, or investigational academic research. Insight Genetics has obtained an exclusive worldwide license from St. Jude Children’s Research Hospital for the detection of ALK inhibitor resistance mutations.
This SBIR award is Insight Genetics’s sixth contract and third consecutive Phase II contract from NCI’s companion diagnostics program. It will enable Insight Genetics to further refine Insight ALK Resistance toward a premarket approval application (PMA) with FDA.
Insight ALK Resistance is currently offered by Insight Molecular Labs, the CLIA-certified subsidiary of Insight Genetics, as a laboratory-developed test. Insight Molecular Labs provides support services for clinical trials on targeted therapeutics, including the identification of appropriate patients for trials, and specializes in the detection and monitoring of molecular-driven drug resistance in patients being treated with specific cancer therapies.
For more information, visit Insight Genetics.