The Decipher Prostate Genomic Classifier is available as part of Veracyte’s Clinical Laboratory Improvement Amendments (CLIA)-validated laboratory developed test (LDT) service. FDA approval or clearance is not required for the Decipher Prostate test.
Veracyte Labs SD, which performs Decipher testing, is accredited/licensed by the following:
- College of American Pathologists
- Centers for Medicare and Medicaid Services (CMS) CLIA
- California Department of Public Health
- New York State Department of Health
- Pennsylvania Department of Health
- State of Rhode Island and Providence Plantations Department of Health Center for Health Facilities Regulation
- Maryland Department of Health, Office of Health Care Quality