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First Expedited NGS Test Breaks Through FDA Review

FDA has approved FoundationOne CDx, the first next-generation sequencing test to clear the agency's expedited access pathway as a breakthrough-designated diagnostic. The companion diagnostic also nabbed a positive national Medicare coverage propose simultaneously thanks to the FDA/CMS Parallel Review Program.

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...

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