Abstract
With the advent of routine predictive biomarking of cancers using immunohistochemistry and in situ hybridization, it has become essential to manage the assays involved with the highest standards of quality assurance at the internal and external quality control levels. This is to ensure the reproducibility and accuracy of generating, interpreting, and reporting what are classified as stand-alone Class III category results. To satisfy this need, it is required to use approved validated and standardized tests applied with suitable on-slide or batch controls to engender adequate internal control-based quality assurance. In addition, it is necessary for the laboratory to participate in external quality assurance schemes to align the performance of the assay and the quality of the assay results with regional, national, and international standards on a regular basis. The chapter is written to provide generic information for the reader on the principles and methodology involved for validation of predictive biomarker assays and the critical issues involved in their regular internal and external quality assurance from a perspective of applying these assays at the level of routine diagnostic laboratories as well as at centers of excellence dealing with the screening and reporting of the results of ongoing clinical trials.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Abbreviations
- BC:
-
Breast cancer
- CAP:
-
College of American Pathologist
- CDx:
-
Companion diagnostics
- EQA:
-
External quality assurance
- GC:
-
Gastric cancer
- HER2:
-
Human epidermal growth factor receptor 2
- IHC:
-
Immunohistochemistry
- IQC:
-
Internal quality control
- MMR:
-
Mismatch repair (MLH1, PMS2, MSH2, MSH6)
- PT:
-
Proficiency testing
References
Duffy MJ, Harbeck N, Nap M, Molina R, Nicolini A, Senkus E, et al. Clinical use of biomarkers in breast cancer: updated guidelines from the European Group on Tumor Markers (EGTM). Eur J Cancer. 2017;75:284–98.
Taylor CR. Predictive biomarkers and companion diagnostics. The future of immunohistochemistry – ‘in situ proteomics’, or just a ‘stain’? Appl Immunohistochem Mol Morphol. 2014;22(8):555–61.
Jørgensen JT. Companion and complementary diagnostics: clinical and regulatory perspectives. Trends Cancer. 2016;2:706–12.
Scheerens H, Malong A, Bassett K, Boyd Z, GuptaV, Harris J, et al. Current status of companion and complementary diagnostics: strategic considerations for development and launch. Clin Transl Sci. 2017;10:84–92.
Siegel J. Department of health & human services. 1998. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf.
Nordi QC. Recommended protocols. 2018. http://www.nordiqc.org/recommended.php
Fitzgibbons PL, Murphy DA, Hammond ME, et al. Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays. Arch Pathol Lab Med. 2010;134:930–5.
ICH Harmonised Tripartite Guideline – validation of analytical procedures: text and methodology Q2(R1). 2005.
Fitzgibbons PL, Bradley LA, Fatheree LA, Alsabeh R, Fulton RS, Goldsmith JD, et al. Principles of analytic validation of immunohistochemical assays – guideline from the College of American Pathologists Pathology and Laboratory Quality Center. Arch Pathol Lab Med. 2014;138:1432–43.
Grzybicki DM, et al. The usefulness of pathologists’ assistants. Am J Clin Pathol. 1999;112:619–26.
Galvis CO, et al. Pathologists’ assistants practice. A measurement of performance. Am J Clin Pathol. 2001;116:816–22.
Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. Arch Pathol Lab Med. 2014;138(2):241–56.
Bartley AN, Washington MK, Ventura CB, Ismaila N, Colasacco C, Benson IIIAB, et al. HER2 testing and clinical decision making in gastroesophageal adenocarcinoma guideline from the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology. Arch Pathol Lab Med. 2016;140:1345–63.
Hammond ME, Hayes DF, Wolff AC, Mangu PB, Temin S. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. J Oncol Pract. 2010;6(4):195–19.
Cree IA, Booton R, Cane P, Gosney J, Ibrahim M, Kerr K, et al. PD-L1 testing for lung cancer in the UK: recognizing the challenges for implementation, Cree et al. Histopathology. 2016;69:177–86.
Krusche CA, von Wasielewski R, Rüschoff J, Fisseler-Eckhoff R, Kreipe HH. Ringversuche zum Nachweis von therapeutischen Zielmolekülen beim Mammakarzinom in Deutschland. Pathologe. 2008;29:315–20.
Garon EB, Rizvi NA, Hui R, Leighl N, Balmanoukian AS, Eder JP, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med. 2015;372(21):2018–28.
Zhu J, Armstrong AJ, Friedlander TW, Kim W, Pal SK, George DJ, et al. Biomarkers of immunotherapy in urothelial and renal cell carcinoma: PD-L1, tumor mutational burden, and beyond. J Immunother Cancer. 2018;6:4.
Rüschoff J, Lebeau A, Kreipe H, et al. Assessing HER2 testing quality in breast cancer: variables that influence HER2 positivity rate from a large, multicenter, observational study in Germany. Mod Pathol. 2017;30:217–26.
Ibrahim M, Parry S, Wilkinson D, et al. ALK immunohistochemistry in NSCLC: discordant staining can impact patient treatment regimen. J Thorac Oncol. 2016;11(12):2241–7.
Scheel AH, Baenfer G, Baretton G, Dietel M, Diezko R, Henkel T, et al. Interlaboratory concordance of PD-L1 immunohistochemistry for non-small-cell lung cancer. Histopathology. 2018;72(3):449–59.
Cheung CC, Garratt J, Won J, et al. Developing ALK immunohistochemistry and in situ hybridization proficiency testing for non-small cell lung cancer in Canada: Canadian immunohistochemistry quality control challenges and successes. Appl Immunohistochem Mol Morphol. 2015;23(10):677–81.
International Quality Network for Pathology. Home page: http://www.iqnpath.org/.
Vyberg M, Nielsen S. Proficiency testing in immunohistochemistry – experiences from Nordic Immunohistochemical Quality Control (NordiQC). Virchows Arch. 2016;468:19–29.
NordiQC. NordiQC assessment scheme 2018. http://www.nordiqc.org/modules.php.
UK NEQAS. International quality expertise. UK NEQAS ICC & ISH modules. http://www.ukneqasiccish.org/modules/.
Quip. Qualitätssicherungs-initiative pathologie QuIP GmbH. Home page: https://quip.eu/en_GB/zerpa/trials/.
European Society of Pathology. EQA schemes; 2018: https://www.esp-pathology.org/esp-foundation/eqa-schemes.html.
College of American Pathologists. Home page: www.cap.org.
Canadian Partnership Against Cancer. Home page: http://cpqa.ca/.
The Royal College of Pathologists of Australasia: Quality Assurance Programs. Home page: https://www.rcpaqap.com.au/.
Kneip Fleury M, Menezes ME, Abol Correa J. Implementation of the external quality assessment program in Brazil. Biochem Med (Zagreb). 2017;27(1):93–6.
Becton, Dickinson and Company. Home page: http://www.bd.com/.
CAP Today. CAP partners with BD in China and India, August 1st, 2013. http://www.captodayonline.com/cap-partners-with-bd-in-china-and-india/.
Xiaojuan L, Qingkai D, Yongmei J. Proficiency testing experience with College of American Pathologists’ Programs at a University Hospital in China from 2007 to 2011. Arch Pathol Lab Med. 2014;138(1):114–20.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2019 Springer Nature Switzerland AG
About this chapter
Cite this chapter
Heinmöller, P., Bänfer, G., Grzelinski, M., Alexander, K.V., Alexander, K.A., Jasani, B. (2019). Quality Control of Immunohistochemical and In Situ Hybridization Predictive Biomarkers for Patient Treatment: Experience from International Guidelines and International Quality Control Schemes. In: Badve, S., Kumar, G. (eds) Predictive Biomarkers in Oncology. Springer, Cham. https://doi.org/10.1007/978-3-319-95228-4_48
Download citation
DOI: https://doi.org/10.1007/978-3-319-95228-4_48
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-95227-7
Online ISBN: 978-3-319-95228-4
eBook Packages: MedicineMedicine (R0)