CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.
The contract covers all of Foundation Medicine's genomic profiling tests, including FoundationOne CDx, FoundationOne Liquid, and FoundationOne Heme.
CMS's move to restrict coverage could limit test access for early-stage cancer patients and negatively impact lab revenues.
MSK researchers showed that high TMB may be associated with improved survival across tumor types, but the cut-offs for high and low status will vary based on histology.
The issue, discovered in late October, affected TMB reporting for up to 800 FoundationOne CDx tests during a short period of time and was quickly resolved.
Foundation Medicine's assay detects genomic alterations in 324 cancer genes and serves as a companion diagnostic for patients with certain types of tumors.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
The CDx, which will include the detection of activating FGFR2 fusions, is expected to be incorporated into Foundation Medicine's FDA-approved FoundationOne CDx assay.
Roche Diagnostics' revenues were driven by its centralized and point-of-care solutions as well as its tissue diagnostics business, both rising in the high-single digits.
The collaboration agreement includes support for development, regulatory submission, and commercialization of tests to guide use of Novartis' drug portfolio.