This report reviews clinical study abstracts and clinical practice guidelines addressing comprehensive molecular profiling (CMP) tests for the intended use as a broad molecular profiling tool (assessing DNA or RNA variants in > 50 genes), to identify biomarkers present in the tumor and then assign matched therapy specific to those biomarkers (may include U.S. Food and Drug Administration [FDA]-approved or off-label use), in patients with solid tumors.

Not included in this report are clinical studies and practice guidelines addressing:

  • CMP via liquid biopsy, or

  • CMP used for the primary purpose of testing 1 or a few predetermined biomarker(s) that has a molecularly related FDA-approved therapy(ies) for the patient’s particular cancer (this use will be referred to as targeted molecular profiling for the remainder of this report).

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