Our Certifications

Clinical Laboratory Improvement Amendments

All US-based partner laboratories are CLIA-certified, meeting federal standards for laboratory testing quality, accuracy, and reliability. CLIA certification is mandated for any laboratory performing testing on human specimens in the United States.

Health Insurance Portability and Accountability Act

BiomarkersLabs and all US partner laboratories comply with HIPAA requirements for the protection of patient health information. Business Associate Agreements (BAAs) are in place with all data processors.

General Data Protection Regulation

BiomarkersLabs complies with GDPR requirements for the collection, processing, and storage of personal data for EU and UK practitioners. Data Processing Agreements (DPAs) are in place with all EU/UK partner laboratories.

Conformité Européenne

Partner laboratory tests distributed in the EU carry CE marking, indicating conformity with applicable EU health and safety legislation.

Personal Information Protection and Electronic Documents Act

BiomarkersLabs complies with PIPEDA requirements for the handling of personal information of Canadian practitioners.

In Vitro Diagnostic Regulation

Partner laboratories serving EU practitioners comply with the EU IVDR framework for in vitro diagnostic medical devices, ensuring tests meet the regulation's requirements for safety and performance.