Clarient Diagnostic Services entered a worldwide licensing agreement for intellectual property from Insight Genetics, granting Clarient rights to develop a genetic test covering the ALK (anaplastic lymphoma kinase) biomarker. Clarient intends to develop and evaluate the performance characteristics of a quantitative PCR-based test that detects increased transcription of the ALK gene.
Rearrangements involving the ALK gene are implicated in non-small-cell lung cancer and other cancers. Several ALK inhibitors are in clinical trials and one, Pfizer’s Xalkori, has been approved by the FDA.
“The National Comprehensive Cancer Network guidelines now suggest ALK testing as a standard measure for all non-small-cell lung cancer patients due to the development of therapies targeting ALK inhibition,” notes Kenneth J. Bloom, M.D., CMO of Clarient.
In addition to the proven role it plays in select lung cancers, ALK has been found to have a pathogenic role in many cancers including diffuse large B-cell lymphoma, inflammatory myofibroblastic tumor, esophageal squamous cell carcinoma, colorectal cancer, and breast cancer, according to Clarient.