Related Experiment Video
Updated: May 12, 2026
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
European consensus conference for external quality assessment in molecular pathology
J H van Krieken1, A G Siebers, N Normanno
1Department of Pathology 824, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
Abstract:
Molecular testing of tumor samples to guide treatment decisions is of increasing importance. Several drugs have been approved for treatment of molecularly defined subgroups of patients, and the number of agents requiring companion diagnostics for their prescription is expected to rapidly increase. The results of such testing directly influence the management of individual patients, with both false-negative and false-positive results being harmful for patients. In this respect, external quality assurance (EQA) programs are essential to guarantee optimal quality of testing. There are several EQA schemes available in Europe, but they vary in scope, size and execution. During a conference held in early 2012, medical oncologists, pathologists, geneticists, molecular biologists, EQA providers and representatives from pharmaceutical industries developed a guideline to harmonize the standards applied by EQA schemes in molecular pathology. The guideline comprises recommendations on the organization of an EQA scheme, defining the criteria for reference laboratories, requirements for EQA test samples and the number of samples that are needed for an EQA scheme. Furthermore, a scoring system is proposed and consequences of poor performance are formulated. Lastly, the contents of an EQA report, communication of the EQA results, EQA databases and participant manual are given.
Insights
External quality assurance (EQA) programs are crucial for accurate molecular pathology testing. A new guideline harmonizes European EQA schemes to ensure reliable tumor testing for patient treatment.
Area of Science:
- Oncology
- Pathology
- Genetics
- Molecular Biology
Background:
- Molecular testing of tumor samples is increasingly vital for guiding cancer treatment decisions.
- The number of drugs requiring companion diagnostics is rapidly growing, emphasizing the need for accurate testing.
- Inaccurate molecular test results (false-negative or false-positive) can significantly harm patients.
Framework:
- A guideline was developed by stakeholders in molecular pathology to harmonize European External Quality Assurance (EQA) schemes.
- Recommendations cover EQA scheme organization, reference laboratory criteria, and test sample requirements.
- The guideline includes a proposed scoring system, consequences for poor performance, and reporting standards.
Implementation:
- The guideline addresses the organization and execution of EQA schemes in molecular pathology.
- It defines criteria for reference laboratories and specifies requirements for EQA test samples.
- Recommendations are provided for scoring, reporting, and communication of EQA results.
Implications:
- Harmonized EQA standards will improve the quality and reliability of molecular pathology testing across Europe.
- Enhanced quality assurance ensures that treatment decisions based on molecular testing are accurate and beneficial for patients.
- Standardized EQA programs support the appropriate use of targeted therapies and companion diagnostics in oncology.
