Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine. Part 3: Technical Validation of Immunohistochemistry (IHC) Assays in Clinical IHC Laboratories

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.; Morphology, Molecular

doi:10.1097/pai.0000000000000470

Cited by 51 publications

(90 citation statements)

References 52 publications

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“…At the same time, different preanalytical conditions such as ischemic time and duration of fixation are difficult to control even in the standardized clinical laboratory settings. Immunohistochemical protocols require continuous optimization through internal and external validation; read-out of the immunohistochemical results is human-dependent and prone to subjective interpretation [ 92 ].…”

Section: Methodological Limitations In the Histopathological Diagnostmentioning

confidence: 99%

Histopathological classification of non-functioning pituitary neuroendocrine tumors

2017

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Non-functioning pituitary neuroendocrine tumors do not cause endocrine symptoms related to hypersecretion of adenohypophyseal hormones and are clinically characterized by symptoms due to growing sellar tumor mass. Histopathological classification of this tumor group has always been challenging due to their heterogeneity, limited knowledge on their biology, and diverse methodological problems. We have searched PubMed database for data related to the histopathological classification of non-functioning pituitary tumors and methods for its application. Principles of the classification and grading presented in the recently released 4th edition of the World Health Organization classification of endocrine tumors have been summarized. Based on the expression of anterior pituitary hormones and pituitary specific transcription factors, gonadotroph tumors dominate within the group of clinically non-functioning tumors, followed by corticotroph type; however, other less common types of the non-functioning tumors can be identified. Assessment of tumor cell proliferation is important to identify “high-risk adenomas.” A few subtypes of non-functioning tumors belong to the category of potentially aggressive tumors, independent of the cell proliferation rate. Here, we present up to date criteria for the classification of clinically non-functioning pituitary tumors, offer a diagnostic approach for the routine clinical use, and emphasize a need for inclusion of prognostic and predictive markers in the classification.

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Section: Methodological Limitations In the Histopathological Diagnostmentioning

confidence: 99%

Histopathological classification of non-functioning pituitary neuroendocrine tumors

2017

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“…In principle, the process for optimizing and validating an RNA-Seq assay draws many parallels to immunohistochemistry, 25 though arguably with many more components. Briefly, once an assay has been Validation-or "confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled" 26 -of the analytical phase is multifaceted.…”

Section: Optimization and Validation Of An Assaymentioning

confidence: 99%

“…In principle, the process for optimizing and validating an RNA‐Seq assay draws many parallels to immunohistochemistry, though arguably with many more components. Briefly, once an assay has been selected for consideration of clinical implementation the treatment conditions—such as RNA quality—must be optimized.…”

Section: Introductionmentioning

confidence: 99%

“…Understandably, it is impossible to assess each and every one of the hundreds‐to‐thousands of genes contained in the assay. This process must nevertheless attempt to address each of the tiers of technical validation (including sensitivity, specificity, and reproducibility), as well as validation of readout accuracy (eg, aligner and fusion caller techniques) . While attempting to control for pre‐analytic variables (eg, RNA input), the cases selected for validation must address the range of material encountered at the institution (eg, tissue types, fixation, decalcification, and sample size) and must include an appropriate number of cases containing independent molecular confirmation (preferably RT‐PCR, NanoString, or RNA‐Seq, in which both fusion genes are known, although FISH and irrefutable fusion‐associated neoplasms [eg, solitary fibrous tumor] may be deemed acceptable), as well as cases known to lack recurrent fusion event (eg, osteosarcoma, myxofibrosarcoma, and so forth).…”

Section: Introductionmentioning

confidence: 99%

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Targeted RNA sequencing: A routine ancillary technique in the diagnosis of bone and soft tissue neoplasms

Dickson

Swanson

2018

Genes Chromosomes & Cancer

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The past decade has witnessed remarkable progress in delineating the molecular pathogenesis of many mesenchymal neoplasms. This, in large part, is attributable to the application of next‐generation sequencing. As these techniques decrease in cost, and increasingly support the use of routine clinical specimens—such as formalin‐fixed paraffin‐embedded tissue and cytology samples—they are beginning to be routinely implemented in diagnostic pathology laboratories. The breadth of testing possible by next‐generation sequencing makes this a useful adjunct for pathologists, particularly with the emergence of targeted therapies. The intent of this article is to share our experience, over 2 years, as an early adopter of targeted RNA sequencing as an ancillary diagnostic technique for fusion gene detection in bone and soft tissue neoplasms.

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“…IHC is routinely used for a wide range of pathology diagnoses; however, there have been difficulties validating and standardizing IHC for reasons such as alternative antibody clone choices, epitope retrieval methodologies, and IHC scoring approaches. 8 RNA in situ hybridization (ISH) has been proposed as an alternative to IHC because of its target sensitivity and specificity, clone and epitope retrieval technique independence, and adaptability for use on autostainers. 9 In this exploratory study, a microarray assay was performed comparing long noncoding RNA (lncRNA) and mRNA expression among breast cancer samples with Oncotype DX (Genomic Health, Inc., Redwood City, CA) 21-gene assay recurrence scores (RS) used as a surrogate for 10 year outcome.…”

Section: Introductionmentioning

confidence: 99%

Microarray and RNA in situ hybridization assay for recurrence risk markers of breast carcinoma and ductal carcinoma in situ: Evidence supporting the use of diverse pathways panels

Evans

Vacek

Sprague

et al. 2019

J of Cellular Biochemistry

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Breast tumor stratification by recurrence‐risk is critical for deciding patient treatment. Here an approach combining cancer pathways microarray data complemented by RNA in situ hybridization (ISH) was investigated as a means for recurrence marker discovery and visualization in pathology specimens. LncRNA and mRNA expressions in breast carcinomas with low (n = 8) vs intermediate/high (n = 10) recurrence‐scores as estimated by 21‐gene assay and pathology review were compared by microarray assay. Tissue microarrays were prepared from breast carcinomas (n = 20) and ductal carcinoma in situ (DCIS) specimens (n = 84 patients) with known outcomes. Thirteen RNA ISH assays were performed: lncRNAs (BBC3‐1, FER3, RAD21‐AS1, ZEB1‐2) and mRNAs (GLO1, GLTSCR2, TGFB1, TLR2) (implicated by the microarray data); MKI67; a pooled panel of recurrence‐associated proliferation markers (BIRC5, Cyclin B1, MKI67, MYBL2, STK15); a pooled panel of non‐proliferation recurrence‐associated markers (CEACAM5, HTF9C, NDRG1, TP53, SLC7A5); and lncRNAs H19 and HOTAIR. Seven lncRNAs and 10 mRNAs showed significantly (P < .05) altered upregulation or downregulation by microarray assay: carcinoma RNA ISH staining did not mirror these patterns. HOTAIR staining was associated with a higher breast cancer recurrence score (P = .0152); qualitatively, H19 was massively expressed in a metaplastic triple negative breast carcinoma. Among the DCIS cohort, significant associations with multiple outcome variables were noted for TGFB1 and the non‐proliferation panel (P‐value range: .0001 to .047); proliferation panel staining showed an association with increasing DCIS grade (P = .0269) but not with outcomes. The findings support recurrence‐risk estimation by the use of multi‐marker panels that are representative of diverse cellular pathways rather than over‐reliance on proliferation targets. H19, HOTAIR, and TGFB1 RNA ISH show potential for selective diagnostics.

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Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine. Part 3: Technical Validation of Immunohistochemistry (IHC) Assays in Clinical IHC Laboratories

Cited by 51 publications

References 52 publications

Histopathological classification of non-functioning pituitary neuroendocrine tumors

Histopathological classification of non-functioning pituitary neuroendocrine tumors

Targeted RNA sequencing: A routine ancillary technique in the diagnosis of bone and soft tissue neoplasms

Microarray and RNA in situ hybridization assay for recurrence risk markers of breast carcinoma and ductal carcinoma in situ: Evidence supporting the use of diverse pathways panels

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