How does Everlywell validate the reliability/credibility of your labs?

Everlywell offers consumers access to laboratory-developed tests (LDTs) through our network of CLIA-certified partner laboratories. An LDT is a test that is designed, developed, and performed within a single laboratory. These types of tests are widely used across the United States—not only by Everlywell, but also by large national laboratories such as Quest Diagnostics and Labcorp, as well as thousands of hospital and clinic laboratories.

LDTs fall outside of the FDA’s regulatory authority. Instead, they are overseen by the Centers for Medicare & Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA). Individual states and other entities may also have additional requirements to ensure accurate and reliable testing.

Some of the laboratories Everlywell works with also maintain accreditation from organizations such as the College of American Pathologists (CAP), which CMS has granted deeming authority to perform laboratory inspections in place of CMS.

All of the laboratories that process our tests are CLIA-certified, and some also hold CAP accreditation. These laboratories comply with all federal and state regulations for laboratory testing and conduct frequent internal quality checks, along with regular inspections and validations to ensure testing accuracy.

If you have any questions about the accuracy or quality of your test results, please contact our Customer Experience Team at contact@everlywell.com.