Differential immunocytochemical diagnosis of cancer using...

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G01N 33/574 (2006.01) G01N 33/577 (2006.01) G01N 33/76 (2006.01) G01N 1/30 (2006.01)

Patent

CA 2149617

An immunocytochemical analytic assay for hCG.beta., in a fixed sample of tissues or cells, which uniformly and reliably demonstrates the presence of hCG.beta. in malignant cells of all kinds. Underlying this new method is the realization that it was the omnipresent formalin fixative used in prior art immunocytochemical hCGB assays which irretrievably destroyed the hCG.beta. antigens in oncologic samples and prevented their detection--as well as the realization that not one of the various known unmasking techniques had been able to revive them. The present method includes as an essential step the selection of a non-formalin fixative for use in fixing the tissue or cellular sample to be analyzed, as well as provision for staining and counterstaining to enable positive morphological classification of certain noncancerous cells known to produce hCG.beta.. The present protocol also reflects an underlying new appreciation that because hCG.beta. can be detected in malignant cells of all malignant neoplasm(s), the use of the present immunocytochemical method plus particular morphological classification of noncancer cells can positively identify malignancy in cell or tissue samples 99.9% if not 100% of the time.

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