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Quality Control of Immunohistochemical and In Situ Hybridization Predictive Biomarkers for Patient Treatment: Experience from International Guidelines and International Quality Control Schemes

  • Petra Heinmöller
  • Gudrun Bänfer
  • Marius Grzelinski
  • Katya Victoria Alexander
  • Kathrina A. Alexander
  • Bharat Jasani
Chapter

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.

Keywords

Immunohistochemical predictive cancer biomarkers Assay validation and standardization Internal and external quality control and assurance 

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

  1. 1.
    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.CrossRefPubMedGoogle Scholar
  2. 2.
    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.CrossRefPubMedCentralPubMedGoogle Scholar
  3. 3.
    Jørgensen JT. Companion and complementary diagnostics: clinical and regulatory perspectives. Trends Cancer. 2016;2:706–12.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    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.CrossRefPubMedCentralPubMedGoogle Scholar
  5. 5.
    Siegel J. Department of health & human services. 1998. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf.
  6. 6.
    Nordi QC. Recommended protocols. 2018. http://www.nordiqc.org/recommended.php
  7. 7.
    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.PubMedGoogle Scholar
  8. 8.
    ICH Harmonised Tripartite Guideline – validation of analytical procedures: text and methodology Q2(R1). 2005.Google Scholar
  9. 9.
    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.CrossRefPubMedGoogle Scholar
  10. 10.
    Grzybicki DM, et al. The usefulness of pathologists’ assistants. Am J Clin Pathol. 1999;112:619–26.CrossRefPubMedGoogle Scholar
  11. 11.
    Galvis CO, et al. Pathologists’ assistants practice. A measurement of performance. Am J Clin Pathol. 2001;116:816–22.CrossRefGoogle Scholar
  12. 12.
    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.CrossRefPubMedCentralPubMedGoogle Scholar
  13. 13.
    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.CrossRefPubMedGoogle Scholar
  14. 14.
    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.CrossRefPubMedCentralPubMedGoogle Scholar
  15. 15.
    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.CrossRefPubMedGoogle Scholar
  16. 16.
    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.CrossRefPubMedGoogle Scholar
  17. 17.
    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.CrossRefPubMedGoogle Scholar
  18. 18.
    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.CrossRefPubMedCentralPubMedGoogle Scholar
  19. 19.
    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.CrossRefPubMedGoogle Scholar
  20. 20.
    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.CrossRefPubMedGoogle Scholar
  21. 21.
    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.CrossRefPubMedGoogle Scholar
  22. 22.
    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.CrossRefPubMedGoogle Scholar
  23. 23.
    International Quality Network for Pathology. Home page: http://www.iqnpath.org/.
  24. 24.
    Vyberg M, Nielsen S. Proficiency testing in immunohistochemistry – experiences from Nordic Immunohistochemical Quality Control (NordiQC). Virchows Arch. 2016;468:19–29.CrossRefPubMedGoogle Scholar
  25. 25.
    NordiQC. NordiQC assessment scheme 2018. http://www.nordiqc.org/modules.php.
  26. 26.
    UK NEQAS. International quality expertise. UK NEQAS ICC & ISH modules. http://www.ukneqasiccish.org/modules/.
  27. 27.
    Quip. Qualitätssicherungs-initiative pathologie QuIP GmbH. Home page: https://quip.eu/en_GB/zerpa/trials/.
  28. 28.
    European Society of Pathology. EQA schemes; 2018: https://www.esp-pathology.org/esp-foundation/eqa-schemes.html.
  29. 29.
    College of American Pathologists. Home page: www.cap.org.
  30. 30.
    Canadian Partnership Against Cancer. Home page: http://cpqa.ca/.
  31. 31.
    The Royal College of Pathologists of Australasia: Quality Assurance Programs. Home page: https://www.rcpaqap.com.au/.
  32. 32.
    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.CrossRefGoogle Scholar
  33. 33.
    Becton, Dickinson and Company. Home page: http://www.bd.com/.
  34. 34.
    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/.
  35. 35.
    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.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Petra Heinmöller
    • 1
  • Gudrun Bänfer
    • 2
  • Marius Grzelinski
    • 3
  • Katya Victoria Alexander
    • 3
  • Kathrina A. Alexander
    • 4
  • Bharat Jasani
    • 4
  1. 1.Department of Quality ManagementTargos Molecular Pathology GmbHKasselGermany
  2. 2.Department of Advance -Training and ConsultingTargos Molecular Pathology GmbHKasselGermany
  3. 3.Laboratory for Study Analytics 2Targos Molecular Pathology GmbHKasselGermany
  4. 4.Department of PathologyTargos Molecular Pathology GmbHKasselGermany

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