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The new Consortium for Analytic Standardization in Immunohistochemistry (CASI) has been launched to build foundational evidence for integration of analytic standards into the routine practice of clinical and clinical research [...], * Context.--The authors announce the launch of the Consortium for Analytic Standardization in Immunohistochemistry, funded with a grant from the National Cancer Institute. As with other laboratory testing, analytic standards are important for many different stakeholders: commercial vendors of instruments and reagents, biopharmaceutical firms, pathologists, scientists, clinical laboratories, external quality assurance organizations, and regulatory bodies. Analytic standards are customarily central to assay development, validation, and method transfer into routine assays and are critical quality assurance tools. Objective.--To improve immunohistochemistry (IHC) test accuracy and reproducibility by integrating analytic standards into routine practice. To accomplish this mission, the consortium has 2 mandates: (1) to experimentally determine analytic sensitivity thresholds (lower and upper limits of detection) for selected IHC assays, and (2) to inform IHC stakeholders of what analytic standards are, why they are important, and how and for what purpose they are used. The consortium will then publish the data and offer analytic sensitivity recommendations where appropriate. These mandates will be conducted in collaboration and coordination with clinical laboratories, external quality assurance programs, and pathology organizations. Data Sources.--Literature review and published external quality assurance data. Conclusions.--Integration of analytic standards is expected to (1) harmonize and standardize IHC assays; (2) improve IHC test accuracy and reproducibility, both within and between laboratories; and (3) dramatically simplify and improve methodology transfer for new IHC protocols from published literature or clinical trials to clinical IHC laboratories. doi: 10.5858/arpa.2022-0031-RA

The time has come to regulate clinical immunohistochemistry (IHC) as an assay rather than a stain. Since IHC originally evolved as an extension of special stains in anatomic pathology, (1) [...]

The prognostic significance of LEA.135 expression, detected by immunohistochemistry in formalin-fixed and paraffin-embedded tissue sections, was evaluated and compared with the widely utilized clinicopathological parameters for patients with primary invasive breast carcinomas. Pathological parameters such as tumor size, histological tumor type, histological grade, nuclear grade, lymph node (LN) status, bone marrow (BM) status, as well as age of patient at initial diagnosis together with follow-up in years were available for this group of patients (n = 178). Among these parameters, tumor size, histological tumor type, histological grade, LN status, and BM status were individually and significantly associated with increased probability of recurrence by univariate analysis. By multivariate analysis, however, only tumor size, LN status, and BM status remained statistically significant. LEA.135-positive patients showed a statistically significant probability of not recurring (77 +/- 5% at 5 years after surgery) compared with patients who were LEA. 135-negative (49 +/- 6% at 5 years after surgery) (log-rank p < 0. 001). Furthermore, the association remained statistically significant by multivariate analysis (log-rank p = 0.019), demonstrating that LEA.135 expression independently and significantly identified breast cancer patients with favorable clinical outcome. In addition, there was a statistically significant association between loss of LEA.135 expression and poor prognosis when patients were stratified by pathological parameters. Furthermore, a subgroup of patients who were LEA. 135-positive/LN-negative experienced a decreased rate of recurrence compared with those who were LEA.135-negative/LN-negative (16% vs. 27%, respectively). A similar result was also obtained when BM-negative patients were stratified on the basis of LEA. 135-positive or LEA.135-negative subgroups for recurrence (18% vs. 43%, respectively). Most interestingly, the patients whose cancer cells were LEA.135-positive/LN-positive experienced a much lower rate of recurrence than those whose cells were LEA. 135-negative/LN-positive (29% vs. 57%, respectively). The results clearly demonstrate that LEA.135 expression was a significantly independent and favorable prognostic marker for patients with primary invasive breast carcinoma by both univariate and multivariate analyses.