Precision Medicine Insights

Precision Medicine Insights are non-analytical reports about genetic testing for rare inherited diseases that de- scribe findings from MEDLINE, genetic data- bases, and professional society websites. Includes abstracts from English-language, peer- reviewed clinical trials and review articles, information related to applicable regulatory approvals, National Coverage Determinations by CMS and major private payers, and to high- quality online sources.

Comprehensive Molecular Profiling of Circulating Solid Tumor DNA for the Intended Use as a Broad Molecular Profiling Tool for Monitoring

This report reviews clinical study abstracts and clinical practice guidelines addressing comprehensive molecular profiling (CMP) of circulating solid tumor DNA as a broad molecular profiling tool to aid in monitoring for indicators of treatment response/failure or tumor progression. This report will focus solely on free ctDNA detected in plasma separated from whole blood samp…

Comprehensive Molecular Profiling of Circulating Solid Tumor DNA for the Intended Use as a Broad Molecular Profiling Tool to Aid Treatment Selection

This report reviews clinical study abstracts and clinical practice guidelines addressing comprehensive molecular profiling (CMP) of circulating solid tumor DNA as a broad molecular profiling tool to aid in decision making regarding biomarker-matched treatment selection (including U.S. Food and Drug Administration [FDA]-approved or off-label use). This report will focus solely…

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 Ad…

Tuberous Sclerosis Complex

This report reviews clinical study abstracts and clinical practice guidelines addressing genetic testing for tuberous sclerosis complex (TSC).