Insight Genetics Awarded Qualifying Therapeutic Discovery Program Grant

Insight Genetics have announced that it has been awarded a $244,479 grant to advance the development of novel molecular diagnostic tests for cancer. The grant was awarded by the Internal Revenue Service and the U.S. Department of Health and Human Services as part of the Qualifying Therapeutic Discovery Project Program (QTDP), which was established under the Patient Protection and Affordable Care Act of 2010. The QTDP was created to support innovative, therapeutic projects that result in new therapies, reduce long-term healthcare costs, address unmet medical needs, or significantly advance the goal of curing cancer.

"Insight Genetics is honored to have been selected for the Qualifying Therapeutic Discovery Project Program," said Dr. Christopher Callaghan, President and COO of Insight Genetics. "Our company is uniquely positioned to significantly improve cancer care and outcomes. This grant will allow us to advance new diagnostic tests that will help physicians identify which patients are likely to benefit from certain cancer treatments and monitor the effectiveness of cancer therapies."
Insight Genetics was awarded the grant based on its development of assays for detection of mutations in the anaplastic lymphoma kinase (ALK) gene, which have been shown to have a pathogenic role in many types of cancer, including non-small cell lung cancer (NSCLC), diffuse large B-cell lymphoma (DLBCL), anaplastic large cell lymphoma (ALCL), neuroblastoma (NBL) and inflammatory myofibroblastic tumors (IMT). Cancers associated with ALK mutations are responsible for more than 250,000 new cancer diagnoses in the United States each year. Several ALK inhibitor therapies are in development and assays that can accurately detect ALK mutations will be necessary to identify patients who will benefit from ALK inhibitor therapies.

Insight Genetics' Insight ALK Screen™ assay offers labs a unique, patent-pending method for detecting the presence of any ALK fusion or mutation. It uses a real-time PCR platform, which is standard technology for any molecular lab, and provides faster, more reliable and cost-effective results than currently available methods.

Also in development are Insight ALK Resistance Monitoring™ assays that detect mutations which indicate resistance to ALK inhibitor therapy. These assays will be important for monitoring therapy and selecting patients for second-generation ALK inhibitors. Insight's development effort has been supported by an ongoing collaboration with Dr. Stephan Morris of St. Jude Children's Research Hospital, who originally discovered the ALK oncogene and mutations conferring resistance to ALK inhibition