Analytical Accuracy Validation Testing Planning for a Next-Generation Sequencing Cancer Monitoring Test in a Clinical Laboratory

My project explored the analytical accuracy validation testing process, including the regulations governing it and recommendations for successful execution. The analytical accuracy validation testing was conducted for a next-generation sequencing-based molecular residual disease test to be performed in a clinical laboratory. This test is used to monitor cancer recurrence in cancer patients who have gone through treatment. The project assessed the requirements for completing analytical validation and reviewed results from similar tests to understand what a successful validation entails. The project also evaluated the lessons learned so far from the validation testing my team was performing and outlined what went well and what could be improved.