Foundation Medicine’s Tumor Test Gets FDA Approval

Foundation Medicine has been granted FDA premarket approval for its liquid-biopsy platform, a test that analyzes genes and genomic signatures to inform treatments of solid-tumor cancers.

The platform, FoundationOne Liquid CDx, is now approved to serve as a companion diagnostic to identify patients that may benefit from certain approved targeted therapies, including Rubraca (rucaparib), a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor for prostate cancer, and three first-line tyrosine kinase inhibitors for treating non-small cell lung cancer.

The FDA also approved the liquid biopsy as a comprehensive genomic test for patients with any solid tumor, so it’s approved to detect alterations in more than 300 genes and genomic signatures.

The test provides comprehensive genomic profiling results, reporting on genomic alterations that include genomic signatures and single-gene alterations.