How does Everlywell validate the reliability/credibility of your labs?
Everlywell offers consumers access to our network of labs’ Laboratory Developed Tests (LDTs). An LDT is generally considered to be a test that is designed, developed, and performed within a single laboratory. There are an estimated 11,000 labs offering as many as 100,000 LDTs in the US. At this time, the FDA exercises enforcement discretion over LDTs. Clinical laboratories are regulated by the Centers for Medicare & Medicaid Services (CMS), through the Clinical Laboratory Improvement Amendments (CLIA). States and other entities also oversee lab testing to ensure accurate and reliable test results when laboratories perform the testing on patient specimens. For example, CMS granted the College of American Pathologists (CAP) Laboratory Accreditation Program deeming authority, which allows CAP to conduct laboratory inspections in lieu of a CMS inspection.
All of the laboratories that process our tests are CLIA-certified; some are also CAP-accredited. These labs comply with all federal and state regulations regarding laboratory testing in addition to performing frequent internal quality checks and testing, as well as regular inspections and validation of the accuracy of their testing.
If you have questions about accuracy or quality of your test results please contact Everlywell by emailing us at [email protected]