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NCI Awards Insight Genetics $1.5M to Further Develop NSCLC Assay

NEW YORK (GenomeWeb News) – Insight Genetics today announced it was awarded a $1.5 million Phase II Small Business Innovation Research contract from the National Cancer Institute to continue development of a diagnostic test aimed at non-small cell lung cancer.

The Fast Track contract will go toward the further development of a panel of assays for identifying and characterizing ongogenic ROS1, RET, and DEPDC1 in a population of NSCLC patients who are triple negative for mutations in EGFR, KRAS, or ALK, the Nashville, Tenn.-based company said.

ROS1 and RET fusions, together with DEPDC1 expression, are estimated to comprise up to 9 percent of all NSCLC cases, and patients with these biomarkers are among those with the poorest prognosis, Insight said.

Several drugs are under development that target RET and ROS1, while peptide vaccines for DEPDC1 are currently in Phase I/II clinical trials. However, there are no high-throughput commercial diagnostics that have been approved by regulatory agencies that can reliably and efficiently identify the biomarkers, according to Insight.

As part of the Phase II contract, the company will continue to analytically and clinically validate three real-time qPCR-based NSCLC assays — the Insight ROS Screen, the Insight RET Screen, and the Insight DEPCD1 Screen.

Initial experiments have demonstrated high sensitivity and specificity for the assays, with results obtained within 24 hours, the company said.

"ROS1, RET, and DEPDC1 are important biomarkers in the fight to improve outcomes for those with lung cancer," Insight's VP of R&D David Hout said in a statement. "Cancer therapies targeting these genetic markers have shown great promise, but we need effective and robust diagnostics to help identify the patients who can benefit from these treatments."

The contract builds on a Phase I Fast Track $199,576 contract by NCI awarded to Insight in November that supported R&D work directed at a panel of companion diagnostic tests for detecting RET, ROS1, and DEPDC1 mutations in NSCLC. At the same time, the company also received a $1.5 million Phase II award to further develop its Insight ALK Screen.

In April, Insight said NCI chose the company to participate in the institute's Clinical Assay Development Program, which seeks to move promising assays to clinical trials from the research laboratory. Insight has access to two CLIA-certified labs for further validation of the Insight ALK Screen, as a result of its inclusion in the program.