Comprehensive Molecular Profiling Test(s) for Solid Tumors Intended to be Used as Broad Molecular Profiling Tool to Assigned Matched Therapy

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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