What are the steps to validate a new genomic assay

Validating a new genomic assay involves several critical steps. First, the assay’s analytical validity must be established, which includes assessing its sensitivity, specificity, accuracy, and reproducibility. This is followed by clinical validation to determine its effectiveness in a real-world setting. Key performance metrics are evaluated through pilot studies and comparisons with existing standards or assays. Rigorous documentation and peer review are integral to the validation process, ensuring transparency and compliance with regulatory guidelines. Continuous monitoring and periodic re-validation are also essential to maintain assay credibility. Key Takeaway: Genomic assay validation ensures reliability through rigorous analytical and clinical evaluations.