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multi-cancer early detection screening test

Defined in 1 place of the United States Code.

The term “multi-cancer early detection screening test” means a test furnished to an individual for the concurrent detection of multiple cancer types across multiple organ sites on or after January 1, 2029, that—

(A) is cleared under section 360(k) of title 21, classified under section 360c(f)(2) of title 21, or approved under section 360e of title 21;

(B) is—

(i) a genomic sequencing blood or blood product test that includes the analysis of cell-free nucleic acids; or

(ii) a test based on samples of biological material that provide results comparable to those obtained with a test described in clause (i), as determined by the Secretary; and

(C) the Secretary determines is—

(i) reasonable and necessary for the prevention or early detection of an illness or disability; and

(ii) appropriate for individuals entitled to benefits under part A or enrolled under part B.

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