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Ventana, Quintiles to Offer CDx Testing Services in China for Early Phase Cancer Studies

NEW YORK (GenomeWeb) – Roche subsidiary Ventana Medical Systems has signed an agreement with contract research organization Quintiles to offer companion diagnostic testing services to drug developers performing early stage oncology studies in China.

Ventana said in a statement that the CDx testing services it will be offering with Quintiles will follow College of American Pathology standards. "It's been extremely important to Ventana that we find a strategic laboratory in China that will help us uphold the CAP testing standard of excellence set by our global companion diagnostic CAP/CLIA laboratory in Tucson, Arizona," James Hnatyszyn, director of lab operations for Ventana companion diagnostic services, said in a statement. China requires that samples of patients in the country, even those involved in clinical trials, are tested within its borders.

According to World Health Organization statistics, in 2012 China had 3.07 million new cancer cases, marking it the highest rate recorded globally. The incidence is growing particularly in lung, liver, esophageal, and stomach cancers. "This underscores the growing need for patients in China to have in-country access to the most advanced tissue diagnostic testing and companion therapeutics in the industry, which starts with early phase clinical trials," Ventana said in a statement.

Ventana has been focusing on expanding its presence in China. The Chinese Food and Drug Administration last year approved the Ventana ALK Rabbit Monoclonal Primary Antibody assay as a companion diagnostic for Pfizer's non-small cell lung cancer drug Xalkori (crizotinib). The agency approved the test to identify NSCLC patients who are ALK-positive based on data from a retrospective study involving 1,100 Chinese patients.

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