Regulatory Information

VeriStrat^® was developed, and its performance characteristics were determined, by Biodesix, Inc. The U.S. Food and Drug Administration (FDA) has not reviewed or approved VeriStrat. VeriStrat is performed in compliance with the requirements for high complexity tests under the Clinical Laboratory Improvement Amendments of 1988, as amended, and its implementing regulations. VeriStrat is only available in the jurisdictions in which the Biodesix has received a license or permit to provide the test.

Clinical Laboratory Improvement Amendments (CLIA) Accreditation Number: 06D1090464

Health Insurance Portability and Accountability Act (HIPAA) Compliance

Biodesix is in full compliance with HIPAA, enacted in 1996, which requires covered entities to mitigate, to the extent practicable, any harmful effect that is known to the entity as a result of any unauthorized use or disclosure of protected health information by the entity or its business associates. Biodesix will work with your organization to ensure that the Act is upheld and enforced in all business arrangements.