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Medical Letter on the CDC & FDA

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Diagnostics



Cancer-detection company comments on study citing efficacy of toluidine blue



October 23rd, 2005

Zila, Inc. (ZILA) commented on a recent journal article in which the authors address the potential efficacy of toluidine blue in identifying high-risk oral pre-malignant lesions.

Douglas D. Burkett, PhD, Zila's chairman, president and CEO, confirmed that the article indicates that the toluidine blue used in the Canadian study is the company's proprietary Zila Tolonium Chloride (ZTC). This patented pharmaceutical-grade form of toluidine blue has not been approved by the U.S. Food and Drug Administration (FDA) for the identification of oral pre-malignant lesions; however, Zila is in the process of initiating a new clinical trial for the purpose of gaining FDA approval of...


Source: Medical Letter on the CDC & FDA (2005-10-23)

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