uPath HER2 (4B5) image analysis, Breast

Pathologist-annotated viable tumor region in images of formalin-fixed, paraffin-embedded invasive breast cancer tissue.

The uPath HER2 (4B5) algorithm reports the HER2 score for both ROI and an aggregate score for all selected ROIs on that slide.

The uPath HER2 (4B5) algorithm is designed to work with the VENTANA HER2/neu (4B5) Rabbit Monoclonal Primary Antibody. The test results are the same level of quality and accuracy as the immunohistochemistry (IHC) stained slide that is imaged and the subsequent image that is analyzed. The uPath HER2 (4B5) algorithm is not tested, nor its safety and effectiveness validated for use on a personal computer (PC) from home. Validate the staining run by examining the run controls. Verify that the expected results are obtained before the uPath software acquires the sample slide images. VENTANA HER2/neu (4B5) antibody, including all positive and negative quality control materials for each staining run. If the control slides are unacceptable, restain the tissue until acceptable results are obtained. The uPath HER2 (4B5) algorithm must be used with histological examination, proper controls, and a qualified pathologist. • If the slide images exhibit abnormal staining or are improperly scanned, the uPath HER2 (4B5) algorithm may generate incorrect scores. • The uPath HER2 (4B5) algorithm is validated on ductal, lobular, mucinous, medullary, papillary, and micropapillary breast carcinomas, and a few metastatic lesions. Samples covered grades 1–3, scores 0–3+, and tissue biopsies, and resections. • The uPath HER2 (4B5) algorithm is a tool that identifies positively stained tumor cell membrane and calculates the HER2 score. The uPath HER2 (4B5) algorithm may reject tumor nuclei that are elongated regardless of the overall shape of the cell. For this reason, tumors containing large numbers of cells with elongated tumor nuclei must be evaluated manually. The uPath HER2 (4B5) algorithm identifies DAB stained membranes of any intensity and completeness. It uses a noise threshold of 0.5% of all tumor cells to score a case as 1+, and scores negative cases as 0. It does not follow the method sheet guidelines of using a one cell threshold for a score of 1+. The tools within the uPath enterprise software are discussed in more detail in the staining characteristics section. The uPath HER2 (4B5) algorithm is sensitive to the color brown (DAB staining) to ensure even faint membrane staining is detected. For this reason, it can incorrectly score a tissue sample containing brown artifacts such as pigmentation, background staining in muscle fibers, or any other artifacts that are stained brown. There are tools within the uPath enterprise software that allow the pathologist to exclude such areas. The uPath HER2 (4B5) algorithm is sensitive for 2+ cases. For this reason, the uPath HER2 (4B5) algorithm may incorrectly score certain 1+ cases as 2+. Specifically, 1+ cases with slightly less than 10% of tumor cells with complete staining, or cases with a high amount of tumor cell cytoplasmic staining, may be incorrectly scored as 2+. The pathologist may override the score in these particular types of cases. The uPath HER2 (4B5) algorithm may interpret nonspecific basal staining as membrane staining, resulting in an incorrect HER2 score. A manual override may be required in this case.