Clinical genomics laboratories operate under healthcare regulations to produce patient-specific results used for diagnosis or treatment, requiring formal accreditation (e.g., CLIA in the U.S.) and compliance with standards like CAP or ISO 15189. Their outputs are validated reports with defined clinical performance characteristics, traceable quality controls, and documented result release processes. Research genomics labs, by contrast, primarily generate data for discovery, publication, or development, often without returning results to individuals and typically without the same regulatory oversight. They prioritize scientific exploration, method development, and hypothesis testing, with more flexible change management. Key differentiators include: validated assays versus exploratory methods; formal quality management systems versus research best practices; PHI handling under HIPAA for clinical operations; and reportable ranges and decision thresholds defined through analytical validation. Collaboration is common—research labs may develop assays that are transferred to clinical labs for validation. For organizations spanning both, clear separation of workflows, data governance, consent, and facility access is critical to maintain compliance while enabling innovation.
Key Takeaway: Clinical labs are regulated to deliver validated patient reports; research labs focus on discovery with flexible methods and fewer regulatory constraints.