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Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies
Published on: April 11, 2016
Next generation diagnostic molecular pathology: critical appraisal of quality assurance in Europe
Hendrikus J Dubbink1, Zandra C Deans2, Bastiaan B J Tops3
1Department of Pathology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA Rotterdam, The Netherlands.
Abstract:
Tumor evaluation in pathology is more and more based on a combination of traditional histopathology and molecular analysis. Due to the rapid development of new cancer treatments that specifically target aberrant proteins present in tumor cells, treatment decisions are increasingly based on the molecular features of the tumor. Not only the number of patients eligible for targeted precision medicine, but also the number of molecular targets per patient and tumor type is rising. Diagnostic molecular pathology, the discipline that determines the molecular aberrations present in tumors for diagnostic, prognostic or predictive purposes, is faced with true challenges. The laboratories have to meet the need of comprehensive molecular testing using only limited amount of tumor tissue, mostly fixed in formalin and embedded in paraffin (FFPE), in short turnaround time. Choices must be made for analytical methods that provide accurate, reliable and cost-effective results. Validation of the test procedures and results is essential. In addition, participation and good performance in internal (IQA) and external quality assurance (EQA) schemes is mandatory. In this review, we critically evaluate the validation procedure for comprehensive molecular tests as well as the organization of quality assurance and assessment of competence of diagnostic molecular pathology laboratories within Europe.
Insights
Diagnostic molecular pathology faces challenges in comprehensive tumor testing. This review evaluates validation and quality assurance for European labs offering precision medicine.
Area of Science:
- Oncology
- Pathology
- Molecular Biology
Background:
- Tumor evaluation increasingly combines histopathology and molecular analysis for targeted cancer therapies.
- The rise of precision medicine necessitates comprehensive molecular testing of tumors.
- Diagnostic molecular pathology laboratories face challenges in delivering accurate, timely results from limited tissue samples.
Purpose of the Study:
- To critically evaluate validation procedures for comprehensive molecular tests.
- To assess the organization of quality assurance in diagnostic molecular pathology laboratories across Europe.
- To review the competence assessment of these laboratories.
Main Methods:
- Review of validation procedures for molecular pathology tests.
- Analysis of quality assurance (internal and external) schemes.
- Evaluation of laboratory competence assessment frameworks.
Main Results:
- Validation is crucial for accurate and reliable molecular test results.
- Robust quality assurance programs are essential for diagnostic molecular pathology.
- Standardized competence assessment is needed for European laboratories.
Conclusions:
- Effective validation and quality assurance are paramount for reliable molecular diagnostics.
- Harmonized approaches to quality assurance and competence assessment are needed in Europe.
- Addressing laboratory challenges ensures the success of precision medicine initiatives.
