This is a great question, but it’s not the right question!

Laboratory developed tests like ours are not currently evaluated by the FDA. Laboratory testing is regulated according to what’s called the Clinical Laboratory Improvement Amendments, or CLIA (pronounced “klee-yuh”). CLIA compliance is monitored by three federal agencies: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). Each agency has a unique role in assuring quality laboratory testing.

COLA (the Commission on Office Laboratory Accreditation) is a separate private, physician-directed non-profit organization that helps labs meet the highest standards for quality and operate in compliance with federal and state regulatory requirements.

In addition to this, we run our own dedicated laboratory. Operating our own lab allows us to ensure that every test is done to the same exacting quality standards that we pride ourselves on!