TriPath Imaging Inc.
TriPath Imaging Inc. of Burlington,
N.C., has received the FDA’s 510(k) approval to use the Ki-67 cell proliferation
biomarker with the Ventana Image Analysis System from Ventana Medical Systems Inc.
of Tucson, Ariz. The biomarker enables pathologists to determine the percentage
of tumor cells that are actively dividing with precise quantitative measurements
of the biomarker’s expression in breast biopsy samples. The approach is expected
to aid scientists in further investigations into the correlation between proliferation
rate and survival.
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