Certifications

The Biodesix Clinical Laboratory Improvement Amendments (CLIA)-certified facility provides the quality and reproducibility that is a hallmark of centralized diagnostic testing. Our technology platforms include MALDI-ToF mass-spectrometry, multiple PCR platforms including droplet digital™ PCR, as well as capabilities to perform NGS testing. Our research, product development and laboratory operations teams align to develop and deliver tests that accommodate high volumes of blood samples per day with the rapid and accurate results that physicians and patients demand.

We deliver validated tests through our Laboratory, and our pharma and biotech partners have the ability to test clinical samples under CLIA standards and an ISO13485-certified Quality Management System. The Laboratory operates under Good Laboratory Practice, and all personnel are trained to follow strict confidentiality guidelines in accordance with Health Insurance Portability and Accountability Act (HIPAA) standards.

Boulder Business License (pdf)

California – Clinical Laboratory License (pdf)

CMS CLIA Certification of Accreditation (pdf)

College of American Pathologists (CAP) Accreditation (pdf)

Florida – Clinical Laboratory License (pdf)

ISO Certification (pdf)

Maryland – Medical Laboratory Permit (pdf)

New York – Clinical Laboratory Permit (pdf)

New York – Laboratory Director Certification (pdf)

Pennsylvania – Clinical Laboratory Permit (pdf)

Rhode Island – Clinical Laboratory Certification (pdf)

 

 

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