Foundation Medicine Inc.'s FoundationOne CDx, a multi-drug companion diagnostic test, was approved by via US FDA's Breakthrough Device Program and gained a simultaneous national Medicare coverage policy proposal under the FDA/CMS' Parallel Review Program, making it the first in vitro diagnostic to successfully clear both programs simultaneously. It is also only the second device to reach this stage in the parallel-review process.
FoundationOne CDx, also known as F1CDx, is a next-generation sequencing IVD that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. This means...