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Chinese Regulators Approve Ventana's Assay as CDx for Xalkori

NEW YORK (GenomeWeb News) – The Chinese Food and Drug Administration has approved the Ventana ALK immunohistochemistry assay as a companion diagnostic for Pfizer's Xalkori (crizotinib) therapy, Ventana Medical Systems said today.

The Ventana ALK Rabbit Monoclonal Primary Antibody assay is for identifying non-small cell lung cancer patients who are ALK-positive, and approval came after a retrospective study was conducted that included 1,100 Chinese patients. In the study, the assay demonstrated about 99 percent concordance with Abbott's Vysis ALK Break Apart FISH Probe Kit, Ventana, a Roche company, said.

The US Food and Drug Administration approved Xalkori and Abbott's test as a companion diagnostic for the drug in 2011.

The ALK, or anaplastic lymphoma kinase, fusion gene is associated with pathologic expression of the ALK fusion protein, and inhibiting the ALK tyrosine kinase has resulted in tumor shrinkage for ALK-positive patients, Ventana said. Xalkori, it added, is an oral first-in-class ALK inhibitor that has been shown to block important growth and survival pathways, which may shrink or slow the growth of tumors.

The drug is indicated for treating locally advanced or metastatic ALK-positive NSCLC. In addition to regulatory approval in China, Ventana's assay is CE marked with a claim to identify patients eligible for treatment with Xalkori.

Along with closely collaborating with Roche country affiliates, Ventana said that it has worked with more than 45 biopharmaceutical partners during the past decade and is working on more than 150 collaborative projects to develop and commercialize companion diagnostics globally.