Product News: Ventana Announces Collaboration to Develop ALK Companion Diagnostic Test

20 Jan 2012

Ventana Medical Systems, Inc., a member of the Roche Group, has announced that it has entered into a collaboration agreement with Pfizer Inc. and a license agreement with Cell Signaling Technology (CST) to develop an immunohistochemistry (IHC) companion diagnostic test for ALK gene rearrangements.

The test will be the first fully automated and standardized IHC test for ALK gene rearrangements. It measures the associated protein product when an ALK gene rearrangement is present.

The purpose of the test is to identify non-small cell lung cancer (NSCLS) patients with anaplastic lymphoma receptor tyrosinekinase (ALK) who may benefit from Pfizer’s XALKORI® (crizotinib), which was approved in the US in August of 2011.

Under the terms of the agreements with Pfizer Inc. and CST, 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.

“At Ventana our mission is to improve the lives of all patients afflicted with cancer,” said Mara G. Aspinall, President of Ventana Medical Systems, Inc. “We believe this collaboration will provide enormous benefit to patients suffering from NSCLC through biomarker identification. Our early development data suggests that the combination of CST’s D5F3 antibody and VENTANA OptiView detection generates a highly sensitive assay that detects cases with very low expression of the ALK protein in lung tissue which means that XALKORI may be an appropriate treatment for those patients.”

The determination of the presence of ALK gene rearrangements helps physicians to select more specific therapies for NSCLC patients, including XALKORI. The benefits of IHC testing include laboratory workflow automation, speed, and cost effectiveness. The broad availability of IHC testing on VENTANA instruments will also benefit physicians and patients worldwide.