Home » IMMUNICON ANNOUNCES RECEIPT BY VERIDEX OF ADDITIONAL
IMMUNICON ANNOUNCES RECEIPT BY VERIDEX OF ADDITIONAL
Immunicon Corporation announced today that it has been informed by Veridex,
a Johnson & Johnson company, that Veridex has received clearance from the
U.S. Food and Drug Administration (FDA) of a pre-market notification, or 510(k),
regulatory submission in which Veridex provided additional data from Immunicon's
clinical trial in metastatic breast cancer for inclusion in the package insert
of the CellSearch Circulating Tumor Cell (CTC) Kit. These data, related to the
relationship between CTCs and progression free survival and overall survival
at additional time points during therapy, were presented at the 2005 Annual
Meeting of the American Society of Clinical Oncology (ASCO) in May.
Yahoo News
KEYWORDS FDAnews Device Daily Bulletin
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