InsightGeneticslogoInsight Genetics Inc, Nashville, Tenn, has received a Phase II Small Business Innovation Research (SBIR) contract from the National Cancer Institute (NCI) to continue its development of a diagnostic test for the diagnosis and treatment of non-small cell lung cancer (NSCLC).

The new contract for nearly $1.5 million continues work the NCI began funding in 2012.

The company 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.

There are several therapies targeting RET and ROS1 with fewer yet also promising strategies against DEPDC1 in development. ARIAD’s Iclusig® (ponatinib), Bayer’s Nexavar® (sorafenib), and Exelexis’ Cometriq® (cabozantinib) target RET. Compounds at different stages of clinical development that target ROS1 include Pfizer’s Xalkori® (crizotinib), ARIAD’s AP26113, Synta’s HSP90 inhibitor ganetespib, and Xcovery’s X-396. DEPDC1/MPHOSH1 peptide vaccines are currently in Phase I/II clinical trials. Unfortunately, there are currently no regulatory-approved, high-throughput commercial diagnostics to reliably and efficiently identify these biomarkers.

It furthers the development of a panel of assays designed to provide a fast and accurate way to identify and characterize oncogenic ROS1, RET, and DEPDC1 in a population of NSCLC patients who are triple negative for mutations in EGFR, KRAS, or ALK. Collectively, ROS1 and RET fusions, along with DEPDC1 expression, have been estimated to constitute up to 9% of all NSCLC cases, and people who carry these biomarkers are among those with the poorest prognoses.

Companion diagnostic tests such as those the company is developing allow physicians to screen cancer patients for particular biomarkers, such as genetic mutations or dysregulation of gene expression. The results can indicate if a targeted therapy is more likely to be effective for a patient and provide indication on the most tolerable and effective dose.

[Source: Insight Genetics]