Christopher Callaghan DPAChristopher Callaghan, DPAInsight Genetics, Nashville, Tenn, which has developed a diagnostic test that can 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, 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% to 10% of lung cancers.

Insight ALK Screen is inexpensive, highly sensitive, and well suited to handling large numbers of specimens. 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. It provides rapid, unambiguous identification of the complete spectrum of oncogenic ALK fusion mutations unachievable by more conventional PCR strategies, the company says. Its ease of use and rapid turnaround time will decrease the time in which physicians and their patients receive information.

“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, Insight Genetics.

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 3 years the molecular diagnostics company has been awarded four contracts from NCI for the development of companion diagnostics.

[Source: Insight Genetics]