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Insight Genetics Launches Insight Molecular Labs

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Insight Genetics announce the launch of Insight Molecular Labs. The laboratory provides clinical trial support services for targeted therapeutics, assisting in the identification of appropriate patients for trials, and specializes in the detection and monitoring of drug resistance in patients being treated with specific cancer therapies. 

“We are excited to launch Insight Molecular Labs,” said Eric Dahlhauser, Chairman and CEO of Insight Genetics. “The laboratory is a natural extension of Insight Genetics’ work and will help us leverage our scientific expertise and specialized experience in resistance detection and monitoring to assist physicians in making therapy decisions and help identify patients for clinical trials. We look forward to the future of Insight Molecular Labs and the contributions it will make to enhancing drug development and patient care.”

Targeted therapeutics have been developed that inhibit known genetic drivers, such as EGFR and ALK. However, most patients develop resistance to these inhibitors within a year. Inhibitor resistance may be due to mutations within the primary oncogenic driver gene, or as a result of a secondary pool of cancer cells arising from a mutation in a separate gene. Knowing the molecular driver of a patient’s inhibitor resistance can assist a physician in choosing the appropriate ongoing treatment for the patient, which could be a next-generation inhibitor or another therapy that targets a separate oncogenic driver. 

“Inhibitor resistance is a hurdle we must overcome as we fight cancer with precision medicine,” said Stephan W. Morris, MD, Scientific Founder & Chief Scientific Officer of Insight Genetics and the first to identify the oncogenic properties of ALK fusions and ALK inhibitor resistance mutations. “The tests offered through Insight Molecular Labs can help identify, monitor and manage a cancer patient’s disease. Our goal is to contribute to a patient’s care throughout their lives by providing versatile and robust laboratory-developed tests that are a resource for clinicians as well as pharmaceutical, biotech and research organizations. Insight Molecular Labs will use its expertise in identifying key mechanisms of resistance to advance precision cancer care.” 

Insight Molecular Labs’ diagnostic tests, developed through Insight Genetics’ companion diagnostic assay development program, include:

• Insight ALK Screen™ is a highly reliable PCR-based assay that detects expression of ALK. Insight ALK Screen avoids the limitations of other ALK test methods with a unique design that allows for the detection of both known and unknown ALK fusions as well as full-length ALK. Insight ALK Screen provides information useful for clinical trial enrollment and treatment guidance. Turnaround time for this test is 24-48 hours and requires minimal tissue.

• Insight ALK Resistance™ is a PCR-based test that is customizable to focus on all clinically identified resistance mutations in the ALK kinase domain or specific mutations, providing the desired information required to select appropriate patient cohorts for clinical trials or treatment with a second generation ALK inhibitor. The Insight ALK Resistance assay has a rapid turnaround time of 24-48 hours, with minimal tissue requirements. Insight Genetics has exclusive worldwide rights from St. Jude Children’s Research Hospital for the detection of ALK inhibitor resistance point mutations.

• Insight Resistance ID™ Next Generation Sequencing panel is a comprehensive assay reporting multiple mechanisms of resistance that have been identified as potential therapeutic targets, including separate and secondary mutations in EGFR, ALK, KRAS and BRAF. This assay can be used to profile a number of patients at once, with a turnaround time of 10-14 days. Insight Molecular Labs also is planning to offer a breakthrough, blood-based version of this assay in the near future, which will eliminate challenges such as limited tumor tissue sample or the need to obtain serial biopsies.

In addition to these assays, Insight Molecular Labs offers molecular tests to aid physicians in identifying known oncogenic drivers including EGFR, KRAS and BRAF. 

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.