Nucleix Receives CAP Accreditation and CLIA Certification for its San Diego Clinical Laboratory
Thursday, October 20, 2022
Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced that their San Diego-based clinical laboratory received accreditation by the College of American Pathologists (CAP). This achievement follows the recent certification under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services. These designations highlight the commitment, work ethic and quality demonstrated by the laboratory team.
“As we ramp up research and laboratory operations to evaluate, develop and commercialize methylation-based assays for early cancer detection, receiving these designations provides validation of our ability to accept and report on clinical samples,” said Chris Hibberd, Chief Executive Officer at Nucleix. “We are proud of these achievements as we continually seek opportunities to optimize our efforts and ultimately, build technology solutions that help physicians and their patients diagnose cancer earlier, when treatment is most effective.”
The CAP Laboratory Accreditation Program is the gold standard for laboratory excellence. Their program fosters an environment for continuous improvement and patient safety.
CLIA certification confirms that Nucleix’s clinical laboratory meets the federal regulations for clinical diagnostic testing, ensuring high quality and safety for patient testing. As part of the certification process, Nucleix completed analytical and clinical validation evaluating the accuracy and reliability of its EpiCheck early detection test platform.