Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine – Part 2: Immunohistochemistry Test Performance Characteristics

Torlakovic, Emina; Cheung, Carol C.; D’Arrigo, Corrado; Dietel, Manfred; Francis, Glenn; Gilks, C. Blake; Hall, Jacqueline A.; Hornick, Jason L.; Ibrahim, Mostafa; Marchetti, Antonio; Miller, Keith; Krieken, J. Han van; Nielsen, Søren Laurentius; Swanson, Paul E.; Vyberg, Mogens; Zhou, Xiaoge; Taylor, Clive R.

doi:10.1097/pai.0000000000000444

Cited by 41 publications

(42 citation statements)

References 40 publications

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“…Adjustment of the IHC protocol for PCSK2 (30,31) and evaluation of the primary antibody specificity was based on a literature review of the enzyme location in normal NE tissues and NE cell components (5,20,21). In the accepted IHC setting, the enzyme was expressed in the expected histological (NE cells, islet of Langerhans) and cellular (cytoplasmic) locations (32).…”

Section: Immunohistochemistrymentioning

confidence: 99%

PCSK2 expression in neuroendocrine tumors points to a midgut, pulmonary, or pheochromocytoma–paraganglioma origin

Remes

Leijon

Vesterinen

et al. 2020

APMIS

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Neuroendocrine tumors (NETs) are often diagnosed from the metastases of an unknown primary tumor. Specific immunohistochemical (IHC) markers indicating the location of a primary tumor are needed. The proprotein convertase subtilisin/kexin type 2 (PCSK2) is found in normal neural and neuroendocrine cells, and known to express in NETs. We investigated the tissue microarray (TMA) of 86 primary tumors from 13 different organs and 9 metastatic NETs, including primary tumor-metastasis pairs, for PCSK2 expression with polymer-based IHC. PCSK2 was strongly positive in all small intestine and appendiceal NETs, the so-called midgut NETs, in most pheochromocytomas and paragangliomas, and in some of the typical and atypical pulmonary carcinoid tumors. NETs showing strong positivity were re-evaluated in larger tumor cohorts confirming the primary observation. In the metastases, the expression of PCSK2 mirrored that of the corresponding primary tumors. We found negative or weak staining in NETs from the thymus, gastric mucosa, pancreas, rectum, thyroid, and parathyroid. PCSK2 expression did not correlate with Ki-67 in well-differentiated NETs. Our data suggest that PCSK2 positivity can indicate the location of the primary tumor. Thus, PCSK2 could function in the IHC panel determined from screening metastatic NET biopsies of unknown primary origins.

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Section: Immunohistochemistrymentioning

confidence: 99%

PCSK2 expression in neuroendocrine tumors points to a midgut, pulmonary, or pheochromocytoma–paraganglioma origin

Remes

Leijon

Vesterinen

et al. 2020

APMIS

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“…The aim of EQA accuracy assessment is to demonstrate that the LDT protocol performs as it should in a specific type of tumor (with specificity for predefined types of cells/tissues, appropriate subcellular signal localization, etc.). 66 This is not to be confused with indirect clinical validation in which a larger number of randomly selected cases is used and evaluated against a reference standard IHC assay (see below). 55,57…”

Section: Eqa Accuracymentioning

confidence: 99%

Fit-For-Purpose PD-L1 Biomarker Testing For Patient Selection in Immuno-Oncology: Guidelines For Clinical Laboratories From the Canadian Association of Pathologists-Association Canadienne Des Pathologistes (CAP-ACP)

Cheung

Barnes

Bigras

et al. 2019

Applied Immunohistochemistry &Amp; Molecular Morphology

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Since 2014, programmed cell death protein 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) checkpoint inhibitors have been approved by various regulatory agencies for the treatment of multiple cancers including melanoma, lung cancer, urothelial carcinoma, renal cell carcinoma, head and neck cancer, classical Hodgkin lymphoma, colorectal cancer, gastroesophageal cancer, hepatocellular cancer, and other solid tumors. Of these approved drug/disease combinations, a subset also has regulatory agency-approved, commercially available companion/ complementary diagnostic assays that were clinically validated using data from their corresponding clinical trials. The objective of this document is to provide evidence-based guidance to assist clinical laboratories in establishing fit-for-purpose PD-L1 biomarker assays that can accurately identify patients with specific tumor types who may respond to specific approved immunooncology therapies targeting the PD-1/PD-L1 checkpoint. These recommendations are issued as 38 Guideline Statements that address (i) assay development for surgical pathology and cytopathology specimens, (ii) reporting elements, and (iii) quality assurance (including validation/verification, internal quality assurance, and external quality assurance). The intent of this work is to provide recommendations that are relevant to any tumor type, are universally applicable and can be implemented by any clinical immunohistochemistry laboratory performing predictive PD-L1 immunohistochemistry testing.

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“…Laboratory errors may thus result in wrong or suboptimal treatment decisions and consequently in patient harm. To assure high-quality testing, laboratories should have a quality assurance (QA) system in place and comply with relevant (inter)national standards such as from the International Organization for Standardization (ISO), the College of American Pathologists (CAP), or the Clinical Laboratory Improvement Amendments (CLIA) [1][2][3][4][5][6]. External quality assurance (EQA), one important component of QA, mostly is a service to diagnostic laboratories by assessment of their testing procedures compared with their peers and/or "designated true value."…”

Section: Introductionmentioning

confidence: 99%

Biomarker testing in oncology – Requirements for organizing external quality assessment programs to improve the performance of laboratory testing: revision of an expert opinion paper on behalf of IQNPath ABSL

et al. 2020

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In personalized medicine, predictive biomarker testing is the basis for an appropriate choice of therapy for patients with cancer. An important tool for laboratories to ensure accurate results is participation in external quality assurance (EQA) programs. Several providers offer predictive EQA programs for different cancer types, test methods, and sample types. In 2013, a guideline was published on the requirements for organizing high-quality EQA programs in molecular pathology. Now, after six years, steps were taken to further harmonize these EQA programs as an initiative by IQNPath ABSL, an umbrella organization founded by various EQA providers. This revision is based on current knowledge, adds recommendations for programs developed for predictive biomarkers by in situ methodologies (immunohistochemistry and in situ hybridization), and emphasized transparency and an evidence-based approach. In addition, this updated version also has the aim to give an overview of current practices from various EQA providers.

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Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine – Part 2: Immunohistochemistry Test Performance Characteristics

Cited by 41 publications

References 40 publications

PCSK2 expression in neuroendocrine tumors points to a midgut, pulmonary, or pheochromocytoma–paraganglioma origin

PCSK2 expression in neuroendocrine tumors points to a midgut, pulmonary, or pheochromocytoma–paraganglioma origin

Fit-For-Purpose PD-L1 Biomarker Testing For Patient Selection in Immuno-Oncology: Guidelines For Clinical Laboratories From the Canadian Association of Pathologists-Association Canadienne Des Pathologistes (CAP-ACP)

Biomarker testing in oncology – Requirements for organizing external quality assessment programs to improve the performance of laboratory testing: revision of an expert opinion paper on behalf of IQNPath ABSL

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