Insight Genetics Launches Insight RET Screen™, A Novel Solution For Biomarker-Driven Lung Cancer

Diagnostics Company Develops Assay to Detect Targetable Cancer Driver

Nashville, TN (Marketwired) - Insight Genetics, Inc. today announced the launch of its Insight RET Screen™, a Clinical Laboratory Improvement Amendments (CLIA)-validated assay available through Insight Molecular Labs, that detects oncogenic RET (Rearranged during Transfection) expression in non-small cell lung cancer (NSCLC) patients. The Insight RET Screen is a qPCR assay that detects RET expression driven by chromosomal fusions regardless of the fusion partner.

The current standard in diagnostic assay-drug development partnerships has been to use RET fluorescence in situ hybridization (FISH) to identify patients for clinical trial enrollment. Insight Genetics' novel solution provides results within 48 hours or less and with minimal tissue requirement. In a head-to-head comparison to a RET FISH assay, the Insight RET Screen identified 67% more patients who were RET fusion-positive. The Insight RET Screen complements the portfolio of assays currently offered by Insight Molecular Labs that detect targetable mutations, including: ALK, ROS1, EGFR, KRAS, and BRAF.

"A number of targeted RET inhibitors are already in development or approved for patients with thyroid cancer and are currently under investigation in non-small cell lung cancer," said Dr. Stephan Morris, Scientific Founder and Chief Scientific Officer of Insight Genetics. "The Insight RET Screen offers a diagnostic solution to help inform physician decisions for NSCLC, especially for patients who are negative for molecular drivers such as EGFR, KRAS, and ALK. We are excited to launch our Insight RET Screen to help identify patients who will benefit from these targeted therapies, both through physician-ordered testing and in clinical trials."

Chromosomal fusions involving the RET tyrosine kinase gene are driver mutations in papillary thyroid cancer and in approximately 2% of lung cancers. In NSCLC, the most frequently observed fusion partner with the RET kinase domain is the KIF5B gene (62%) with a smaller fraction fused with the CCDC6 (16%) or NCOA4 genes (8%). The kinase activity of RET is directed toward signaling substrates that regulate genes associated with increased cell survival and proliferation. A number of tyrosine kinase inhibitors have shown promise against RET-driven cancers.

The Insight RET Screen was developed with support from Phase I and Phase II National Cancer Institute Small Business Innovation Research (SBIR) contracts.

About Insight Molecular Labs
Insight Molecular Labs is a CLIA-certified laboratory. CLIA (Clinical Laboratory Improvement Amendments) certification as mandated by federal regulations ensures consistent, accurate, and reliable clinical test results reporting and is required for Medicare reimbursement. In addition to the Insight RET Screen, Insight Molecular Labs offers molecular tests to aid physicians in identifying other known oncogenic drivers including ALK, ROS1, EGFR, KRAS and BRAF, as well as causes of targeted inhibitor resistance. For additional information including test menu and ordering instructions, please visit Insight Molecular Labs atwww.insightmdx.com.

About Insight Genetics
Insight Genetics is dedicated to improving the lives of cancer patients through advanced molecular diagnostics that enable precision in cancer care. The company specializes in the discovery, development and commercialization of molecular diagnostics that detect specific cancer biomarkers and assist in guiding the effective diagnosis and treatment of cancer. Insight Genetics is ISO 9001:2008 certified and partners with leading academic researchers, pharmaceutical and biotechnology companies, clinical reference laboratories, and IVD kit manufacturers to create new standards of care for cancer patients worldwide. Visitwww.insightgenetics.com for more information.