Ventana, Pfizer, and CST Collaborate on Companion Diagnostic

(Tucson, AZ, USA), a member of the Roche Group, has entered into a collaboration agreement with Pfizer Inc. (New York, NY, USA) and a licensing agreement with Cell Signaling Technology (CST; Danvers, MA, USA) to develop a fully automated and standardized immunohistochemistry (IHC) companion diagnostic test for ALK gene rearrangements. The collaboration is a significant step in the war against non-small-cell lung cancer (NSCLC).

The test, which will be developed by Ventana, will identify NSCLC patients with anaplastic lymphoma receptor tyrosinekinase (ALK) gene rearrangements who may benefit from Pfizer's xalkori (crizotinib), approved in the United States in August 2011. The test will measure the associated protein product when an ALK gene rearrangement is present.

The Ventana ALK IHC diagnostic test will be based on CST's D5F3 antibody and Ventana OptiView DAB detection, for performance on Ventana automated platforms.

NSCLC is the world's number one cause of cancer related death, the most common form being adenocarcinoma. Determination of the presence of ALK gene rearrangements helps physicians select more specific therapies for NSCLC patients, including xalkori. The benefits of IHC testing include laboratory workflow automation, speed, and cost effectiveness.

As new biomarker and diagnostic tests become increasingly available, they provide valuable information about potential recipients for these novel agents. Matching specific drugs to specific cancer types, or fitting the treatment to the patients, is at the heart of Roche's vision for "Personalized Healthcare.”

Related Links:
Ventana Medical Systems, Inc.
Pfizer Inc.
Cell Signaling Technology