On August 26th, 2020, the Food and Drug Administration (FDA) approved the FoundationOne Liquid CDx for comprehensive liquid biopsy biomarker testing for patients with any solid tumor. The FDA based their approval on analysis from multiple clinical validation studies which showed that FoundationOne Liquid CDx is very sensitive and specific in finding mutations.

This approval gives patients more options for comprehensive liquid biopsy biomarker testing that were not previously available.

FDA Approval
Meaningful Breakdown of the FDA Approval from The ASCO Post