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Dx Focus: Insight Genetics Launches CLIA-Certified Lab


Nashville, Tenn.-based Insight Genetics said this week that it has launched Insight Molecular Labs, a CLIA-certified laboratory.

The new lab offers diagnostic tests that identify specific cancer biomarkers, provides clinical trial support services for targeted therapeutics; assists in the identification of appropriate patients for trials; and specializes in detecting and monitoring drug resistance in patients being treated with specific cancer therapies.

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

• Insight ALK Screen, a 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, the company said. The assay provides information useful for clinical trial enrollment and treatment guidance with minimal tissue and a turnaround time of 24 to 48 hours

• Insight ALK Resistance, 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. This test also has minimal tissue requirements and a turnaround time of 24 to 48 hours. 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, a next-generation sequencing panel 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 to 14 days. Insight Molecular Labs is also planning to offer a blood-based version of this assay in the near future.

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