advanced diagnostic laboratory test

(5) Advanced diagnostic laboratory test defined In this subsection, the term “advanced diagnostic laboratory test” means a clinical diagnostic laboratory test covered under this part that is offered and furnished only by a single laboratory and not sold for use by a laboratory other than the original developing laboratory (or a successor owner) and meets one of the following criteria: (A) The test is an analysis of multiple biomarkers of DNA, RNA, or proteins combined with a unique algorithm to yield a single patient-specific result. (B) The test is cleared or approved by the Food and Drug Administration. (C) The test meets other similar criteria established by the Secretary.


42 USC § 1395m-1(d)(5)

Scoping language

In this subsection
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