A gene lab is a facility that analyzes DNA/RNA to generate genomic insights for healthcare, research, or public health. Clinical genetics labs operate under defined regulatory and accreditation requirements to produce results used in patient care (diagnosis, prognosis, therapy selection). Research genomics facilities focus on discovery, method development, or population studies, and their outputs generally aren’t used to guide individual patient management without additional clinical validation.
Clinical labs must meet CLIA regulations (in the U.S.) for analytical validity, quality systems, personnel qualifications, and proficiency testing. Many also pursue CAP accreditation or ISO-aligned quality frameworks to demonstrate competence. They manage protected health information, follow standardized test validation and reporting practices (e.g., ACMG/AMP), and maintain traceability from specimen intake to result release.
Research labs prioritize flexibility and innovation, often using experimental protocols or emerging methods. While they uphold good scientific practices, they are not required to meet clinical regulatory standards unless they intend to return results for clinical use.
Understanding this distinction is crucial for governance, budgeting, staffing, equipment qualification, data management, and risk controls—especially when a single organization operates both research and clinical programs.
Key Takeaway: Clinical gene labs are regulated for patient-impacting results; research genomics facilities emphasize discovery and innovation without clinical compliance obligations.