NASHVILLE, Tenn.--(BUSINESS WIRE)--

Insight Genetics, Inc. today announced it 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 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 $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 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 percent of all NSCLC cases, and people who carry these biomarkers are among those with the poorest prognoses.

According to the American Lung Association, nearly 375,000 Americans are living with lung cancer. The U.S. Centers for Disease Control and Prevention estimate that lung cancer accounts for nearly 30 percent of all cancer deaths each year, making it the deadliest form of cancer today.

ROS1, RET and DEPDC1 are important biomarkers in the fight to improve outcomes for those with lung cancer, said David Hout, Ph.D., Insight Genetics Vice President of Research and Development. 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. Our team is delighted to continue our collaboration with the NCI to create companion diagnostic tests that can make this possible.

Companion diagnostic tests such as those Insight Genetics 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. Such tests also can help physicians monitor the ongoing effectiveness of targeted medications and help them to determine when a new treatment might be necessary.

There are several therapies targeting RET and ROS1 with fewer yet also promising strategies against DEPDC1 in development. ARIADs Iclusig (ponatinib), Bayers Nexavar (sorafenib), and Exelexis Cometriq (cabozantinib) target RET. Compounds at different stages of clinical development that target ROS1 include Pfizers Xalkori (crizotinib), ARIADs AP26113, Syntas HSP90 inhibitor ganetespib, and Xcoverys 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.

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 hybridization (FISH) detection assays for ROS1 and RET, which are costly, typically less sensitive, and take between 3-7 days to provide results.

This SBIR award is Insight Genetics fifth contract and second consecutive Phase II contract from NCIs Companion Diagnostics program.

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Insight Genetics Awarded National Cancer Institute Contract to Advance Lung Cancer Diagnosis and Treatment

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