Millennium Health, LLC tests were developed and their performance characteristics determined by Millennium Health. These tests have not been cleared or approved by the US Food and Drug Administration. FDA clearance or approval is not required for clinical use. Millennium Health is regulated under CLIA as qualified to perform high-complexity testing, and is accredited by the College of American Pathologists (CAP). These tests are used for clinical purposes and should not be regarded as investigational or for research. The test results should be used with other clinical and diagnostic findings for patient case management.