Insight Genetics Awarded Two National Cancer Institute Contracts to Enhance Precision in Cancer Care

<0> Diagnostics company receives $1.7 million to develop tests for detecting genetic mutations associated with lung cancer </0>

Insight Genetics Awarded Two National Cancer Institute Contracts to Enhance Precision in Cancer Care

Insight Genetics, Inc.Nicole Cottrill, 615-327-7999

Insight Genetics, Inc. today announced it has received two Small Business Innovation Research (SBIR) contracts from the National Cancer Institute (NCI) to continue its work developing diagnostic tests that identify and characterize specific genetic mutations in lung cancer patients. These companion diagnostic tests will be vital tools in enhancing the accuracy of cancer diagnosis and treatment, assisting physicians in determining which targeted cancer therapies are appropriate for specific patients.

Insight Genetics received a $1,495,220 Phase II contract to further develop its proprietary Insight ALK Screen™ that detects the complete spectrum of oncogenic anaplastic lymphoma kinase (ALK) mutations and fusions, which are associated with several types of cancer including non-small cell lung cancer (NSCLC). NCI also awarded the company a Phase I Fast Track contract of $199,576 to support research and development of a panel of companion diagnostic tests for the detection of RET, ROS1 and DEPDC1 mutations in NSCLC.

As part of its Phase II ALK contract, Insight Genetics will continue analytical and clinical validation of Insight ALK Screen, a real-time qPCR-based test being developed on a QIAGEN platform.

ALK fusions and mutations have been shown to be a contributing cause in approximately 5-10 percent of lung cancers. With knowledge of a patient’s ALK status, clinicians can more accurately determine if the patient will respond to ALK-inhibitor therapies, an emerging class of cancer treatments. Since only patients with ALK fusions are likely to respond to ALK inhibitors, accurate diagnostic screening is essential before prescribing ALK-targeted drugs.

“Insight ALK Screenis more sensitive and specific than the other ALK detection methods currently available,” said David Hout, Ph.D., Insight Genetics’ vice president of research and development. “Our test will reduce false-negative calls of ALK status in tumors, which means more patients who may benefit from ALK inhibitor therapies will receive these targeted treatments. Since it is more easily and quickly performed than alternative tests, Insight ALK Screen also will provide actionable information to physicians and their patients in a more timely manner.”

The Phase I Fast Track contract addresses a significant unmet medical need in the diagnosis and treatment of NSCLC. Collectively, RET, ROS1 and DEPDC1 mutations have been estimated to constitute up to 9 percent of all NSCLC cases, but, at present, there are no regulatory-approved, high-throughput commercial diagnostic tests that can reliably and efficiently identify these biomarkers. The Phase I contract funds nine months of work to create a panel test, with the potential to continue into Phase II funding totaling $1,499,412.

“This new NCI contract allows our team to research and develop a panel of assays that detect the presence of oncogenic RET and ROS1 fusions, along with DEPDC1 expression,” continued Hout. “Effectively identifying these biomarkers is the only way to ensure that patients who carry them can benefit from targeted cancer therapies.”

Various therapies targeting RET and ROS1, respectively, have shown good efficacy in clinical trials. Two examples are Bayer’s Nexavar® (sorafenib) for RET and Pfizer’s Xalkori® (crizotinib) that inhibits ROS1 as well as ALK.

“These two new contracts are the third and fourth companion diagnostic awards Insight Genetics has received from NCI since 2010,” said Insight Genetics President and COO Christopher Callaghan. “We are delighted that NCI continues to recognize and support our company’s leadership in developing diagnostics that enable the prescription of targeted cancer therapies and our commitment to improving care for cancer patients worldwide.”

Companion diagnostic tests such as those Insight Genetics is developing allow physicians to screen cancer patients for particular biomarkers, such as genetic mutation or dysregulation of an expression marker. The results can indicate if a targeted therapy is more likely to be efficacious in 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.

According to the American Lung Association, approximately 373,489 Americans are living with lung cancer. The U.S. Centers for Disease Control and Prevention notes that more people die from lung cancer than any other type of cancer, accounting for nearly 30 percent of all cancer deaths. It also is the most common cancer worldwide, accounting for 1.3 million deaths annually.

Insight Genetics is a molecular diagnostics company focused on enabling precision medicine in cancer therapy. The company’s companion diagnostics detect specific cancer biomarkers related to therapeutics that are currently in development or on the market. Insight partners with leading academic researchers, pharmaceutical and biotechnology companies, clinical reference laboratories, and IVD kit manufacturers to provide new standards of care for cancer patients worldwide.

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