FDA has approved the FoundationOne CDx, the first breakthrough-designated, next generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type.
In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.
