Nucleix Receives CAP Accreditation and CLIA Certification for its San Diego Clinical Laboratory

SAN DIEGO & REHOVOT, Israel--(BUSINESS WIRE)--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.

College of American Pathologists (CAP) Accreditation

As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, CAP serves patients, pathologists and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The Accreditation Committee of the College of American Pathologists has awarded this prestigious recognition based on results of a rigorous on-site inspection of the laboratory’s records and quality control of procedures, laboratory staff qualifications, equipment, facilities, safety program, record and overall management. CAP Accreditation is an internationally recognized program that awards accreditation to laboratories that meet stringent requirements of quality, accuracy, and consistency.

Clinical Laboratory Improvement Amendments (CLIA) Certification

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Under provisions of the U.S. Department of Health and Human Services’ CMS, the California Department of Public Health granted the company initial registration for high complexity testing through the CLIA Certification Program and follows California State laboratory licensure.

About Nucleix

Nucleix is a liquid biopsy company revolutionizing cancer treatment with earlier disease detection at a time when intervention can bring the greatest impact for patients. Leveraging NGS and PCR-based epigenetics, the Company’s pioneering testing approach uses methylation-based identification for early-stage and recurring cancer detection. The Company’s non-invasive EpiCheck^® platform delivers highly accurate and sensitive results, all while providing a seamless testing option for patients and the healthcare system. The Company is building an EpiCheck franchise, beginning with the Bladder EpiCheck^® testing kit, marketed in Europe for recurrent bladder cancer and Upper Tract Urinary Cancer. The Company is advancing a Lung EpiCheck test towards commercialization for high-risk individuals, while advancing additional tests for high-risk diseases. For more information, please visit: https://www.nucleix.com.