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

Dufraing, Kelly; Fenizia, Francesca; Torlakovic, Emina; Wolstenholme, Nicola; Deans, Zandra C.; Rouleau, Étienne; Vyberg, Mogens; Parry, Suzanne; Schuuring, Ed; Dequeker, Elisabeth; Normanno, Nicola; Cheetham, Melanie; Patton, S.; Keppens, Cleo; Casteren, Kaat Van; Krieken, J. Han van; Fairley, Jenni; Grassow-Narlik, Maja; Jöhrens, Korinna; Pagliuso, Julia

doi:10.1007/s00428-020-02928-z

Cited by 21 publications

(14 citation statements)

References 37 publications

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“…Challenging samples might be included (albeit educational) with rare variants to assess the inclusion of all relevant mutations or their detection at low allele frequencies. Schemes should thus be fit for purpose [19] and should cover the entire examination process as required by ISO 15189 [15]. As the samples in the EQA scheme were pre-cut and labeled, several pre-analytical steps were outside the study scope.…”

Section: Time Point In the Total Test Process And Cause Of Deviating mentioning

confidence: 99%

“…The providers of these EQA programs are preferably accredited according to ISO 17043:2010 [17], mimic patient samples as closely as possible, and check the entire examination process [15]. EQA providers could guide laboratories by the provision of feedback, reference material, or methodological advice [18,19]. Some providers (such as the CAP and UK NEQAS) already request a root cause analysis from poor performers [7,15], but no data has yet been published.…”

Section: Introductionmentioning

confidence: 99%

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Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys

2020

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External quality assessment (EQA) schemes assess the performance of predictive biomarker testing in lung and colorectal cancer and have previously demonstrated variable error rates. No information is currently available on the underlying causes of incorrect EQA results in the laboratories. Participants in EQA schemes by the European Society of Pathology between 2014 and 2018 for lung and colorectal cancer were contacted to complete a survey if they had at least one analysis error or test failure in the provided cases. Of the 791 surveys that were sent, 325 were completed including data from 185 unique laboratories on 514 incorrectly analyzed or failed cases. For the digital cases and immunohistochemistry, the majority of errors were interpretation-related. For fluorescence in situ hybridization, problems with the EQA materials were reported frequently. For variant analysis, the causes were mainly methodological for lung cancer but variable for colorectal cancer. Post-analytical (clerical and interpretation) errors were more likely detected after release of the EQA results compared to pre-analytical and analytical issues. Accredited laboratories encountered fewer reagent problems and more often responded to the survey. A recent change in test methodology resulted in method-related problems. Testing more samples annually introduced personnel errors and lead to a lower performance in future schemes. Participation to quality improvement projects is important to reduce deviating test results in laboratories, as the different error causes differently affect the test performance. EQA providers could benefit from requesting root cause analyses behind errors to offer even more tailored feedback, subschemes, and cases.

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Section: Time Point In the Total Test Process And Cause Of Deviating mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys

2020

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“…Following sample analysis, participating laboratories produce a written report, which—at least in some EQA programmes—is sent to the EQA provider for review and assessment. Subsequently, EQA providers issue individual feedback reports to help laboratories improve their performance [ 54 ]. EQA providers may publish the laboratory protocols of the most successful participants as a recommendation of best practice and thus help to implement corrective actions in laboratories with poor results.…”

Section: External Quality Assessment/controlmentioning

confidence: 99%

Expert opinion on NSCLC small specimen biomarker testing — Part 2: Analysis, reporting, and quality assessment

et al. 2022

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The diagnostic work-up for non-small cell lung cancer (NSCLC) requires biomarker testing to guide therapy choices. This article is the second of a two-part series. In Part 1, we summarised evidence-based recommendations for obtaining and processing small specimen samples (i.e. pre-analytical steps) from patients with advanced NSCLC. Here, in Part 2, we summarise evidence-based recommendations relating to analytical steps of biomarker testing (and associated reporting and quality assessment) of small specimen samples in NSCLC. As the number of biomarkers for actionable (genetic) targets and approved targeted therapies continues to increase, simultaneous testing of multiple actionable oncogenic drivers using next-generation sequencing (NGS) becomes imperative, as set forth in European Society for Medical Oncology guidelines. This is particularly relevant in advanced NSCLC, where tissue specimens are typically limited and NGS may help avoid tissue exhaustion compared with sequential biomarker testing. Despite guideline recommendations, significant discrepancies in access to NGS persist across Europe, primarily due to reimbursement constraints. The use of increasingly complex testing methods also has implications for the reporting of results. Molecular testing reports should include clinical interpretation with additional commentary on sample adequacy as appropriate. Molecular tumour boards are recommended to facilitate the interpretation of complex genetic information arising from NGS, and to collaboratively determine the optimal treatment for patients with NSCLC. Finally, whichever testing modality is employed, it is essential that adequate internal and external validation and quality control measures are implemented.

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“…Similar initiatives have been taken by international external quality assurance (EQA) agencies [e.g., UK NEQAS ICC & ISH, NordiQC, and European Molecular Quality Network (EMQN)], who put joint efforts to publish the guidelines for EQA. These guidelines aim to improve molecular tests' performance for precision medicine purposes (60).…”

Section: Challenges Ahead: "Next-generation Pathologists" and Precision Medicinementioning

confidence: 99%

The Role of Pathology in the Era of Personalized (Precision) Medicine: A Brief Review

Vranić

Gatalica

2021

ama

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This review provides a brief overview of the state-of-the-art molecular pathology approaches emphasizing the increasingly important pathology role in clinical precision cancer medicine. Recent advances in molecular biology and genetics have tremendously affected the practice of anatomic pathology, gradually transforming it from a morphology-based into a molecular- based discipline. Molecular diagnostics has a long tradition in pathology, especially in clinical pathology. The improvement of methodology for genomic testing in recent years has made it one of the cornerstones of precision cancer medicine. The decisions related to cancer treatments are no longer solely based on the histopathological diagnosis. Various genomic analyses of human cancers are being incorporated into diagnostic and decision-making algorithms. Conclusion. The pathologists continue to play an essential role in developing and implementing molecular and genomic tests in practice and communicate the results and their relevance with clinicians. Such activities are of utmost importance for successfully translating scientific advancements into a benefit to patients (“next-generation pathologists”).

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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

Cited by 21 publications

References 37 publications

Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys

Causes behind error rates for predictive biomarker testing: the utility of sending post-EQA surveys

Expert opinion on NSCLC small specimen biomarker testing — Part 2: Analysis, reporting, and quality assessment

The Role of Pathology in the Era of Personalized (Precision) Medicine: A Brief Review

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