PierianDx Founder and Chief Informatics Officer, Rakesh Nagarajan, has published an article outlining the College of American Pathologists' (CAP) laboratory standards for clinical next-generation sequencing (NGS). The article details comprehensive guidelines aimed at ensuring the accuracy, reliability, and clinical effectiveness of NGS in diagnostics.
These standards focus on several critical areas, including laboratory accreditation, test validation, and ongoing performance monitoring. They require laboratories to validate their NGS assays rigorously, demonstrating that they meet essential criteria such as accuracy, precision, sensitivity, and specificity before clinical use. The guidelines also stress the importance of robust evaluation of bioinformatics pipelines involved in data analysis.
Additionally, the standards advocate for continuous quality control and proficiency testing, encouraging laboratories to engage in external proficiency programs and adhere to standardized practices to reduce variability and errors. CAP emphasizes the necessity for laboratories to keep pace with technological advancements and evolving regulatory requirements to maintain high standards in NGS-based diagnostics, ultimately enhancing patient care by ensuring the safety and efficacy of these tests.
For further details, you can access the complete article below
College of American Pathologists’ Laboratory Standards for Next-Generation Sequencing Clinical Tests [PDF]
College of American Pathologists Archives of Pathology and Laboratory Medicine (DOI:10.5858/arpa.2014-0250-CP)
