Related Experiment Video
Updated: Jun 23, 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
Recommended principles and practices for validating clinical molecular pathology tests
Lawrence Jennings1, Vivianna M Van Deerlin, Margaret L Gulley
1Department of Pathology and Laboratory Medicine, Children's Memorial Hospital, Chicago, Illinois, USA.
Test validation is crucial for clinical molecular diagnostics. This study outlines principles and regulations for introducing DNA and RNA tests, ensuring reliable results in laboratories.
Area of Science:
- Molecular diagnostics
- Clinical laboratory science
Background:
- DNA and RNA testing is expanding across inherited diseases, infectious diseases, cancer, and pharmacogenetics.
- Technological advancements and increased molecular knowledge drive progress in molecular testing.
- Clinical utility requires careful consideration of test limitations and performance characteristics.
Purpose of the Study:
- To present established principles for molecular test validation.
- To review US regulations pertinent to clinical molecular testing.
- To offer a structured approach for implementing molecular tests in clinical labs.
Main Methods:
- Literature review via PubMed.
- Analysis of published guidelines.
- Compilation of information from professional organizations.
Main Results:
- Established principles for test validation identified.
- Relevant US regulations outlined.
- A framework for clinical test validation developed.
Conclusions:
- Resources and recommendations support a robust framework for clinical test validation.
- Ensures reliable and accurate molecular diagnostic testing.
More Related Videos
11:15Next Generation Sequencing for the Detection of Actionable Mutations in Solid and Liquid Tumors
Published on: September 20, 2016
10:21Protocol for HER2 FISH Using a Non-cross-linking, Formalin-free Tissue Fixative to Combine Advantages of Cryo-preservation and Formalin Fixation
Published on: December 25, 2017
Related Concept Videos
Data Validation
Key parameters for method validation include:
Automated Microbial Diagnostics