In today’s rapidly evolving landscape of precision medicine and global clinical research, laboratory quality has become far more than a regulatory requirement—it is the foundation of diagnostic confidence, patient safety, and international collaboration.
Recently, Burning Rock Dx successfully hosted a global webinar titled “From Accreditation to Excellence: Understanding CAP, CLIA, and Quality Systems in Clinical Laboratories.” The session featured Dr. Daniel Chen, Medical Director, and Christina Brown, Quality Manager, who shared expert insights on how laboratories can move beyond basic compliance and achieve operational excellence through robust Quality Management Systems (QMS) and internationally recognized accreditations such as CLIA and CAP.
Why CAP and CLIA Matter—Especially for Global Laboratories
Dr. Chen highlighted that international CLIA/CAP certification is required for any laboratory outside the United States that processes human specimens collected in the U.S.—a critical requirement for global clinical trials and pharmaceutical collaborations.
CAP accreditation, meanwhile, represents a globally recognized benchmark for laboratory quality. With more than 8,000 accredited laboratories across 76 countries, CAP enables standardization, mutual recognition, and trust across borders. For laboratories engaged in precision medicine, particularly in molecular oncology, NGS, and liquid biopsy testing, CAP’s detailed checklists offer a structured pathway to meet rigorous technical and operational standards.
Building a Sustainable Culture of Quality
Christina Brown emphasized that accreditation should be viewed as a starting point rather than the final goal. True excellence is driven by a dynamic and continuously evolving QMS. Key pillars of an effective QMS include:
1. Standardization to ensure consistent and reliable sample handling
2. Continuous improvement to proactively refine workflows and reduce risk
3. Documentation and traceability, ensuring audit readiness and accountability
4. Empowerment and transparency, fostering a non-punitive quality culture
Key Takeaways for Laboratories Worldwide
The webinar underscored several actionable recommendations for laboratories seeking to strengthen quality and compliance:
1. Align early with international standards such as CAP and CLIA to support global trials and partnerships
2. Invest in a robust QMS to reduce operational risk and enhance credibility
3. Apply rigorous validation practices, particularly for NGS and molecular testing
4. Monitor KPIs across pre-analytical, analytical, and post-analytical phases
5. Prepare for inspections as a team through regular audits, training, and proficiency testing
From Accreditation to Excellence
As Dr. Chen concluded, “Quality should be a corporate culture, from top to bottom.” Embracing this mindset enables laboratories to transform accreditation into excellence—ultimately delivering trustworthy diagnostics and improving patient care worldwide.
Webinar Replay
The full webinar recording is available Now
:
About Burning Rock Dx: A Global Partner Built on Quality
As the organization behind today's insights, Burning Rock Dx (NASDAQ: BNR) exemplifies the commitment to global quality standards discussed above. We are a global precision oncology leader, operating a dual-center network of internationally accredited laboratories to support partners worldwide:
Global Accredited Laboratory Network: Our CLIA-certified, CAP-accredited laboratory in Irvine, California (USA), and our CLIA, CAP, ISO 15189, and ISO 13485 accredited laboratory in Guangzhou (China), form a robust backbone for high-throughput clinical testing and R&D. This dual-hub model ensures stringent adherence to both U.S. and international quality regulations.
Comprehensive Quality & Compliance System: Beyond accreditations, our labs are recognized for operational excellence. The Guangzhou site is certified as a “High-throughput Sequencing Laboratory” and has successfully passed over 200 external quality assessments (EQA) from global bodies like CAP, EMQN, and national centers. Our proprietary, integrated systems—from assay biochemistry to a patented LIMS—underpin every test.
Deep Expertise & Strategic Partnerships: Our portfolio, which includes NMPA-approved IVD kits, CE-marked assays, and a PMDA-approved CDx system, alongside FDA and NMPA Breakthrough Device Designations for our multi-cancer early detection test, demonstrates our capability to support the entire oncology development cycle. We are dedicated to partnering with biopharma and clinical labs to advance trials, biomarker research, and real-world diagnostics.
