Nonagen Bioscience Corporation

Regulatory & Accreditation Status

Nonagen Bioscience’s Irvine, California laboratory holds a Certificate of Compliance under the Clinical Laboratory Improvement Amendments (CLIA) issued by the Centers for Medicare & Medicaid Services (CMS). This certification authorizes the laboratory to perform high-complexity testing and provide commercial laboratory services to clinicians across the United States for Nonagen’s Laboratory Developed Test (LDT), Oncuria™.

The laboratory is also accredited by the College of American Pathologists (CAP), reflecting adherence to rigorous standards for quality management, proficiency testing, and ongoing compliance monitoring.

In addition, the Irvine facility maintains applicable state laboratory licenses, including certification from the State of Rhode Island, ensuring that state-specific regulatory requirements are met for specimens originating from those jurisdictions. Nonagen continues to pursue additional state certifications to support expanded national access.

Licenses and Certifications

CAP # 8862074

Rhode Island LCO01879