How does EverlyWell validate the reliability/credibility of your labs?
EverlyWell offers consumers access to our laboratory partners’ Laboratory Developed Tests (LDTs).
An LDT has been defined by the FDA as a test that is intended for clinical use and is designed, manufactured and used 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 has elected to exercise enforcement discretion over the regulation of LDTs. As a result, the FDA does not currently regulate LDTs.
Laboratory testing in the US is also regulated under the Clinical Laboratory Improvement Amendments (CLIA). All of our labs and tests comply with CLIA-mandated regulations, which is primarily administered by the Centers for Medicare & Medicaid Services in partnership with the state health departments. All of EverlyWell’s partner laboratories are CLIA-certified; many are also accredited by the College of American Pathologists (CAP), the gold standard in lab testing quality regulation. All of our lab partners perform third-party proficiency testing and most do so through CAP or equivalent organizations.
All of the laboratories with whom we partner are considered industry leaders in their respective areas, with extensive histories and have performed millions of tests. All of them perform frequent internal quality controls and testing, as well as regular third-party testing for independent validation of the accuracy of their testing. Consistently, such validation shows a >95% degree average of results correlation. These results are continually made available to EverlyWell.
If you have questions about accuracy or quality of your test results please contact EverlyWell by emailing us at [email protected]