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For Second Time, CMS Covers Cancer Test On Day Of FDA Approval

November 30, 2017
For the second time, CMS agreed to cover a companion diagnostic on the day FDA approved it. The parallel review, combined with FDA’s Breakthrough Device Program, got the cancer test approved and covered within six months of FDA receiving the product application. FoundationOne CDx (F1CDx) is the first breakthrough-designated in vitro diagnostic test to provide information on several genetic mutations -- it detects mutations in 324 genes and two genomic signatures in all solid tumors, according to FDA. The new...


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