LuminoDx Achieves CAP Accreditation, Demonstrating Commitment to Highest Standards in Diagnostic Testing
LuminoDx today announced that its diagnostic testing facility has been awarded accreditation by the Accreditation Committee of the College of American Pathologists (CAP) following a comprehensive on-site inspection. This distinguished achievement confirms that the laboratory meets the most rigorous standards for quality, accuracy, and patient safety in laboratory medicine.
The LuminoDx facility is now part of an elite group of CAP-accredited laboratories worldwide.
Validated Excellence in Testing
CAP inspectors reviewed all aspects of the laboratory’s operations, including personnel qualifications, equipment maintenance, quality control procedures, safety programs, and overall management. The inspection process ensures compliance with thousands of specific checklist requirements.
“Receiving CAP accreditation is a tremendous honor and a critical validation of our team’s dedication,” said Yipeng Wang, CEO. “This accreditation demonstrates that LuminoDx operates at the highest level of precision and quality, giving our clinicians and patients complete confidence in the integrity of the diagnostic results we provide. It’s an assurance that we adhere to the global gold standard in laboratory practices.”
Impact on Patient Care and Diagnostics
The CAP Laboratory Accreditation Program is recognized by the U.S. federal government and is considered more stringent than the government’s own inspection program. Achieving this accreditation means LuminoDx provides diagnostic services that:
- Ensure Accuracy: Minimize the chance of errors in testing through strict quality controls.
- Meet Global Standards: Adhere to the latest, globally recognized best practices in laboratory medicine.
- Support Clinicians: Provide reliable, reproducible results necessary for accurate patient diagnoses and treatment planning.
This accreditation covers liver health diagnostics which include HepatotrackTM, a Molecular Diagnostic liquid biopsy that is predictive of acute liver rejection post-liver transplant.
About LuminoDx:
LuminoDx is a San Diego-based diagnostic company specializing in liquid biopsy and molecular testing. With over 80 years of combined expertise in diagnostic development, we are committed to providing innovative solutions for both clinical and research applications. Our flagship offering is a liquid biopsy solution for post-liver transplant management and care. By leveraging proprietary biomarkers, we enable precision monitoring of allograft health, optimize immunosuppression dosing, and reduce the risk of comorbidities. Additionally, we provide services with Olink proteomics analysis, ELISA analysis, spatial biology with ELEMENT’s Aviti24 system, and Laboratory Test Development.
