Clinical laboratories are largely regulated under the Clinical Laboratory Improvement Amendments of 1988, typically referred to as CLIA. CLIA regulations are enforced by the Center for Medicaid and Medicare Services (CMS). FDA historically has not regulated clinical laboratories or the information that they provide to physicians; FDA has restricted their reach to medical device manufacturers — those companies that sell reagents, instruments or software for diagnostic purposes across state lines.
[Note: There are significant changes expected to this environment as soon as a the FDA guidance document — In Vitro Diagnostic Multivariate Index Assays or IVD MIAs — is finalized. Please see that page for more details.]
It is common in this country for clinical laboratories to develop and validate their own diagnostic tests for a variety of conditions. Clinical laboratories are legally allowed to do this as long as the tests are validated and a part of the laboratory’s CLIA license. These in-house tests are commonly referred to in the industry as homebrews, or, more recently, Laboratory Developed Tests (LDTs). CLIA labs are inspected either by personnel from CMS or by third party inspectors such as the College of American Pathologists (CAP). In several states, including California and New York, additional state regulations apply.
Many medical device manufacturers have used the CLIA path to navigate around FDA and get their technology into the clinical market prior to or in lieu of FDA approval. A company can legally set up a clinical laboratory that uses in-house developed tests to produce clinical results. For example, if Artemis produces a product and then sets up and gets CLIA certification for the Artemis Reference Testing Laboratory, Artemis can use the products it manufacturers to produce LDTs and provide clinical results to physicians.
Many companies have CLIA laboratories as part of the diagnostic portion of their business. In addition, there are numerous stand-alone laboratories that develop their own assays and offer diagnostic results. Examples of stand-alone specialty labs include Genomic Health, Inc., XDx and Monogram Biosciences. There are also large reference laboratories such as Quest and LabCorp that also create numerous LDTs.
