Roche receives FDA approval of FoundationOne Liquid CDx, comprehensive pan-tumor liquid biopsy test

August 28, 2020 – Roche (Basel, Switzerland) received U.S. Food and Drug Administration (FDA) approval for FoundationOne Liquid CDx, Foundation Medicine’s comprehensive pan-tumor liquid biopsy test for patients with solid tumors.

FoundationOne Liquid CDx is a comprehensive genomic profiling (CGP) test that analyzes more than 300 cancer-related genes and multiple genomic signatures to optimize patient care. CGP is used to identify unique mutations to determine how a tumor behaves and grows, and these insights can help physicians to determine a personalized treatment plan for each individual patient based on the specific mutations identified.

In addition to the approval of the FoundationOne Liquid CDx as a CGP test for patients with any solid tumor, the FDA approved the test for use as a companion diagnostic to identify patients who may benefit from treatment with certain prostate and lung cancer therapies, including Rubraca (rucaparib), a poly (ADP-ribose) polymerase (PARP) inhibitor for treatment in patients with BRCA 1/2-mutant metastatic castration-resistant prostate cancer, and three first-line tyrosine kinase (TKI) inhibitors for the treatment of patients with non-small cell lung cancer.

Learn More