Ventana Medical Systems will develop the first fully automated and standardized immunohistochemistry (IHC) companion diagnostic test for anaplastic lymphoma receptor tyrosine kinase (ALK) gene rearrangements. The test will identify non-small cell lung cancer patients with ALK gene rearrangements who may benefit from Pfizer's Xalkori® (crizotinib), approved for use in the U.S. last August.
Ventana says its ALK IHC diagnostic test will be based on its OptiView DAB detection system, as well as the ALK antibody D5F3 of Cell Signaling Technology (CST). Ventana entered into a license agreement with CST and a collaboration agreement with Pfizer to develop the test, which will measure the associated protein product when an ALK gene rearrangement is present.
The agreements come six months after CST provided Pfizer with a worldwide nonexclusive license under patent estates pooled by CST and Astellas Pharma relating to cancer enzyme EML4-ALK. CST and a partner own intellectual property directed to the detection of translocations of EML4-ALK.