Insight Genetics, which has developed a diagnostic test to determine if certain lung cancer patients will respond to targeted therapies, has been selected by the National Cancer Institute (NCI) to participate in the Clinical Assay Development Program (CADP). The CADP is an initiative of NCI’s Division of Cancer Treatment and Diagnosis. Its aim is 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% to 10% of lung cancers. According to company representatives, the PCR-based Insight ALK Screen is inexpensive, highly sensitive, and well suited to handle large numbers of specimens; will reduce the false-negative call frequency of ALK status in tumors; and provides rapid, unambiguous identification of the complete spectrum of oncogenic ALK fusion mutations.
“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,” says 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.”
NCI—through the CADP—will support Insight Genetics by providing services of two CLIA-certified labs that will further validate the assay and offer access to clinical samples, subject matter expertise, and statistical consultation. Read more about joint efforts of NCI and Insight Genetics.