The CADP is an initiative of NCI’s Division of Cancer Treatment and Diagnosis, and aims to move promising assays from the research lab into clinical trials.
Insight Genetics’ Insight ALK Screen™ offers comprehensive data that informs a physician if a patient’s cancer is associated with anaplastic lymphoma kinase (ALK) and may respond to ALK-inhibitor therapies, an emerging class of cancer treatments. ALK fusions and mutations have been shown to be a contributing cause in approximately 5-10 percent of lung cancers.
"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," said Christopher Callaghan, President and COO of Insight Genetics. "Assays like our Insight ALK Screen are important advancements in this evolving cancer landscape. We are extremely gratified to further this field and continue our relationship with NCI by participating in the CADP."
Insight ALK Screen is inexpensive, highly sensitive and well suited to handle larger numbers of specimens than the ALK detection methods currently available. The PCR-based test will reduce the false-negative call frequency of ALK status in tumors, which means more patients who may benefit from ALK inhibitor therapies will receive these targeted treatments. In addition, Insight ALK Screen provides rapid, unambiguous identification of the complete spectrum of oncogenic ALK fusion mutations unachievable by more conventional PCR strategies. Its ease of use and rapid turnaround time will decrease the time in which physicians and their patients receive information.
NCI—through the CADP—will support Insight Genetics by providing services of two CLIA-certified labs that will further validate the assay, access to clinical samples, subject matter expertise, and statistical consultation. This collaboration is the continuation of a successful relationship between NCI and Insight Genetics. In the last three years the molecular diagnostics company has been awarded four contracts from NCI for the development of companion diagnostics.