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Dx Focus: Insight Genetics Chosen for NCI Clinical Assay Development Program

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Insight Genetics said this week that it has been chosen to participate in the National Cancer Institute's Clinical Assay Development Program, an initiative of NCI's Division of Cancer Treatment and Diagnostics that seeks to move promising assays to clinical trials from the research lab.

As a result of Insight's inclusion in the program, the company will have access to two CLIA-certified labs to further validate its Insight ALK Screen assay. NCI will also provide access to clinical samples, subject matter expertise, and statistical consultation.

Insight ALK Screen is a PCR-based test intended to help physicians determine whether a patient's cancer is associated with anaplastic lymphoma kinase and may respond to ALK-inhibitors. According to the Nashville, Tenn.-based company, the test is able to handle larger numbers of specimens than other ALK detection methods currently available and will reduce the false-negative call frequency of ALK status in tumors.

Insight also said that the test provides "unambiguous identification of the complete spectrum of oncogenetic ALK fusion mutations unachievable by more conventional PCR strategies."

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