Regulatory Information

VeriStrat® is a laboratory-developed test (LDT).  LDTs are currently regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which established quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results.  The Centers for Medicare & Medicaid Services (CMS) assumes primary responsibility for accrediting laboratories under CLIA.  VeriStrat is performed in Biodesix’s CLIA accredited laboratory (Biodesix CLIA Accreditation Number: 06D1090464) in compliance with the requirements for high complexity tests under CLIA as well as various State regulators.  The FDA has historically exercised enforcement discretion over LDTs and left regulation to CMS. The FDA is seeking guidance related to how the FDA may in the future regulate tests such as VeriStrat.  We anticipate the FDA will continue to exercise enforcement discretion until an appropriate regulatory framework is finalized.

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.