Ventana Medical Systems has signed a collaboration agreement with Pfizer and a license agreement with Cell Signaling Technology (CST) to develop the first fully automated and standardised immunohistochemistry companion diagnostic test for anaplastic lymphoma receptor tyrosinekinase (ALK) gene rearrangements.

Under the agreement, Ventana will develop an assay to detect non-small cell lung cancer patients with ALK gene rearrangements who may benefit from Pfizer’s Xalkori (crizotinib).

The test will measure the associated protein product when an ALK gene rearrangement is present.

The Ventana ALK immunohistochemistry diagnostic test will rely on CST’s D5F3 antibody and Ventana Optiview DAB detection.

Ventana Medical Systems president Mara Aspinall said the partnership is expected to provide benefit to patients suffering from non-small cell lung cancer 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," Aspinall said.

"In line with our vision for ‘Personalised Healthcare’, this agreement will help further our quest to be the companion diagnostics partner of choice to pharma companies worldwide," Aspinall added.

Pfizer Oncology president and general manager Garry Nicholson said the collaboration with Pfizer is to develop an additional testing option to identify non-small cell lung cancer patients with ALK gene rearrangements.

"Pfizer believes that each cancer patient’s tumour is genetically unique and that biomarker testing helps to identify those patients who may benefit from therapy," Nicholson added.

CST president and CEO Michael Comb said the strategic R&D and intellectual property investments made in the area of EML4-ALK translocation detection are being applied to unmet needs in the diagnosis and treatment of cancer patients.