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Call for IHC Laboratory Participants in the Consortium for Analytic Standardization in Immunohistochemistry (CASI)

BCS is proud to announce the launch of the Consortium for Analytic Standardization in Immunohistochemistry (CASI), funded with a grant from the National Cancer Institute. Its mission is to improve immunohistochemistry (IHC) test accuracy and reproducibility by integrating analytic standards into routine practice. To accomplish this mission, the consortium has two mandates: (a) experimentally determine analytic sensitivity thresholds (lower and upper limits of detection) for selected IHC assays, and (b) to inform IHC stakeholders what analytic standards are, why they are important, and how and for what purpose they are used. As such, CASI needs the cooperation from many IHC laboratories who are willing to run one IHCalibrator slide per assay to generate the needed data.

Research Matters

Because IHControls® and IHCalibrators™ are leading-edge technology, they have been the subject of extensive research, much of which is supported by the National Cancer Institute.  Many of the findings were published in prestigious journals in the fields of laboratory medicinehistology and histopathology.

Research Publications​

Standardization of PD-L1 immunohistochemistry

Modern Pathology 2022 35:294–295. DOI: 10.1038/s41379-021-00917-4

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Quantitative comparison of PD-L1 IHC assays against NIST standard reference material 1934

Modern Pathology 2021 35:326–332. DOI: 10.1038/s41379-021-00884-w

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Quantitative Assessment of Immunohistochemistry Laboratory Performance by Measuring Analytic Response Curves and Limits of Detection

Archives of Pathology & Laboratory Medicine, DOI: 10.5858/arpa.2017-0330-OA

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Selecting an Optimal Positive IHC Control for Verifying Antigen Retrieval

Journal of Histochemistry & Cytochemistry, DOI: 10.1369/00221554188240920

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Analytic Response Curves of Clinical Breast Cancer IHC Tests

Journal of Histochemistry & Cytochemistry, DOI: 10.1369/0022155417694869

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The Importance of Epitope Density in Selecting a Sensitive Positive IHC Control

Journal of Histochemistry & Cytochemistry, DOI: 10.1369/0022155417714208

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Development and Validation of Measurement Traceability for In Situ Immunoassays

Clinical Chemistry, DOI: 10.1093/clinchem/hvab008

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A Root Cause Analysis Into the High Error Rate in Clinical Immunohistochemistry

Applied Immunohistochemistry & Molecular Morphology, DOI: 10.1097/PAI.0000000000000750

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Levey-Jennings analysis uncovers unsuspected causes of immunohistochemistry stain variability

Appl. Immunohistochem. Mol. Morphol., 2016 24(10):688-694. DOI: 10.1097/PAI.0000000000000260

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Standardizing immunohistochemistry: A new reference control for detecting staining problems

J. Histochem. Cytochem, 2015 63:681-690. DOI: 10.1369/0022155415588109

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Molecular Mechanisms of Antigen Retrieval: Antigen Retrieval Reverses Steric Interference Caused By Formalin-Induced Crosslinks

Biotechnic & Histochem. 84(5):207-215. DOI: 10.3109/10520290903039078​

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Experimental validation of peptide immunohistochemistry controls

Appl Immunohistochem Mol Morphol . 2009 May;17(3):239-46. DOI: 10.1097/PAI.0b013e3181904379 PMID: 19077907; PMCID: PMC2672113

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Accurate identification of paraprotein antigen targets by epitope reconstruction

Blood 2008 Jan 1;111(1):302-8. doi: 10.1182/blood-2007-05-090654. Epub 2007 Sep 18. PMID: 17878398 PMCID: PMC2200814

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National HER2 proficiency test results using standardized quantitative controls: characterization of laboratory failures

Arch Pathol Lab Med . 2008 Feb;132(2):211-6. doi: 10.5858/2008-132-211-NHPTRU. PMID: 18251579

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A high throughput combinatorial library technique for identifying formalin-sensitive epitopes

J Immunol Methods . 2006 Dec 20;317(1-2):80-9. doi: 10.1016/j.jim.2006.09.009. PMID: 17056057 PMCID: PMC1847343

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Antibodies immunoreactive with formalin-fixed tissue antigens recognize linear protein epitopes

Am J Clin Pathol . 2006 Jan;125(1):82-90. PMID: 16482995

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A molecular model of antigen retrieval using a peptide array

Am J Clin Pathol . 2006 Jan;125(1):91-8. PMID: 16482996

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A water-stable protected isocyanate glass array substrate

Anal Biochem 2004 Mar 1;326(1):55-68. doi: 10.1016/j.ab.2003.11.008. PMID: 14769336

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A molecular mechanism of formalin fixation and antigen retrieval

Am J Clin Pathol 2004 Feb;121(2):190-9. doi: 10.1309/BRN7-CTX1-E84N-WWPL. PMID: 14983931

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A Novel Microscope Slide Adhesive for Poorly Adherent Tissue Sections

Journal of Histotechnology Volume 26, 2003 - Issue 2. https://doi.org/10.1179/his.2003.26.2.117

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A novel quality control slide for quantitative immunohistochemistry testing

J Histochem Cytochem . 2002 Nov;50(11):1425-34. doi: 10.1177/002215540205001101. PMID: 12417607

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Business & Industry Press

Study Establishes Boston Cell Standards’ Calibrated IHC Technology for Companion Diagnostic Immunohistochemistry

April 7, 2022

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Empowering Pathologists by Bringing Reference Standards to IHC

April 4, 2022

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Boston Cell Standards launches consortium for IHC testing

March 11, 2022

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Consortium for Analytic Standardization in Immunohistochemistry

March 9, 2022

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Boston Cell Standards Launches Consortium for Analytic Standardization in Immunohistochemistry (CASI)

March 8, 2022

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Abstracts

Analysis of PD-L1 IHC tests using NIST SRM 1934-traceable reference materials: A new paradigm for development of predictive IHC biomarkers

AACR 2021

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Introduction and clinical validation of metrology standards for immunohistochemistry (IHC); new tool for standardization of estrogen receptor (ER) IHC Assay in Breast Cancer

SABCS 2020

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Posters

Introduction and clinical validation of metrology standards for immunohistochemistry (IHC); new tool for standardization of estrogen receptor (ER) IHC assay in breast cancer

Analysis of PD-L1 IHC assays using NIST SRM 1934-traceable reference materials: A new paradigm for development of predictive IHC biomarkers

Collaborative Studies

Collaborate With Us

As evidenced by the collaborations in our publications, abstracts, posters, and collaborative studies, we value external collaborations that are ultimately aimed at delivering better patient care. If you see an opportunity to improve biomedical testing where we might be able to help, please contact us.

We have a high interest in collaborations leading to IHC assay standardization. Now that IHC laboratories can measure analytic sensitivity (lower limit of detection) by using IHCalibrators™, there is an important pending question for many, possibly most, IHC tests: To identify the analytic sensitivity that best correlates with diagnostically accurate test results. In other words, for IHC tests, what lower limit of detection yields the best fit-for-purpose result? We are looking for surgical pathology collaborators interested in developing data-driven guidelines.