Abstract: A method of tissue analysis integrates a pathology diagnostic step (subjective human inspection of a stained tissue section or image of it) with one or more gene/biomarker tests to enable perform of both procedures side-by-side on the same instrument.

Abstract: An analytical reference for digital histochemistry is constituted of an on-slide standard used to calibrate biomarker expression in biopsy material and tissue sections. The standard consists of one or more calibration standards, which are derived from cell lines that express biomarkers, and are arranged into a calibration array. Expression of the desired biomarkers is validated by Western blotting, flow cytometry, or other methods. The calibration array is applied to a microscopy slide in such a manner that test samples from biopsies or tissue sections, or other cellular material, can also be mounted on the same slide, adjacent to the calibration array. Data obtained from the calibration array can be used to quantify expression of biomarkers in the biopsy material, tissue sections, tissue microarrays, and cellular material, via digital histochemistry.