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Frequently Asked Questions

What is FoundationOne CDx?

Overview What is FoundationOne CDx? FoundationOne CDx is the first FDA-approved tissue-based broad companion diagnostic (CDx) that is clinically and analytically validated for all solid tumors.

What is MSI status for FoundationOne Liquid CDX?

† MSI status will be reported for FoundationOne Liquid CDx samples determined to have high microsatellite instability as a laboratory professional service which is not reviewed or approved by the FDA.

Does FoundationOne CDx report TMB scores?

Currently FoundationOne CDx, FoundationOne Liquid CDx,* and FoundationOne Heme report TMB scores. As TMB is a quantitative genomic signature, current clinical trials are assessing therapeutic response at various cut-off levels in different tumor types.

Are FoundationOne®CDx and FoundationOne® Liquid CDX tests approved for NGS testing?

Our FoundationOne®CDx and FoundationOne®Liquid CDx tests have 60% of all CDx approvals for NGS testing in the United States and Japan – the most of any diagnostic company 1


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