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Insight Genetics to Participate in NCI's Program to Move Assays to Clinical Trials

NEW YORK (GenomeWeb News) – Insight Genetics said Tuesday that it has been chosen by the National Cancer Institute to participate in the institute's Clinical Assay Development Program.

CADP is 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 for further validation of its Insight ALK Screen. NCI will also provide access to clinical samples, subject matter expertise, and statistical consultation.

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

"As cancer treatment becomes increasingly targeted at the molecular level, the development of advanced diagnostics that can inform cancer diagnosis and therapy selection will be vital," Christopher Callaghan, president and COO of Insight Genetics, said in a statement.

The molecular diagnostics firm noted that it has received four contracts from NCI during the past three years to develop companion diagnostics. In November, it received two Small Business Innovation Research grants from NCI to develop companion diagnostic tests aimed at lung cancer.

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