Regulatory Compliance

Aureon Biosciences, Inc. complies with all appropriate regulatory agencies and meets all appropriate standards and certifications. A New York State (NYS) permit covers Aureon Biosciences, Inc. (New York-based laboratories are CLIA-exempt). Additionally, the NYS Department of Health (DOH) regulates Aureon (CLIA 33D1018251). We also hold out-of-state laboratory licensure in California (COS 800266), Florida (800024759), Maryland (1494), Pennsylvania (030916) and Rhode Island (LCO00530).  Finally, Aureon Biosciences, Inc. is accredited by the College of American Pathologists (LAP 1413381).

Aureon Biosciences is:

• Compliant with the Clinical Laboratory Evaluation Program (CLEP)
• Compliant with 42 CFR Parts 160-164 / HIPAA
• Compliant with 21 CFR Part 58 / GLP
• Compliant with ICAO 650
• Compliant with IEEE standards
• Compliant with OSHA

Aureon's laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and is qualified to perform high-complexity clinical testing. Aureon's tests can be used for clinical purposes and the results presented are adjunctive to the ordering physician’s workup.