advanced diagnostic laboratory test
Defined in 1 place of the United States Code.
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.
Source
- 2014–present42 U.S.C. § 1395m-1The Public Health and Welfare · Improving policies for clinical diagnostic laboratory tests · in this section