Foundation Medicine Announces Final National Coverage Determination (NCD) from the Centers for Medicare & Medicaid Services (CMS), Including Coverage for FoundationOne CDx™ Across All Solid Tumors

Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the Centers for Medicare & Medicaid Services (CMS) issued a final National Coverage Determination (NCD) for patients who receive next generation sequencing (NGS) testing with an assay that meets the coverage criteria. Medicare and Medicare Advantage patients who receive testing with FoundationOne CDx™, the first FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors incorporating a broad set of companion diagnostics, will be eligible for coverage. Below is an outline of key changes made to the final NCD that expand patient access to FoundationOne CDx:

			Preliminary NCD			Final NCD
Patient Eligibility			Coverage for Stage IV metastatic, recurrent cancers			Coverage for Stage III and Stage IV, metastatic, recurrent, relapsed, or refractory cancers
Breadth of Coverage for FoundationOne CDx			Coverage for companion diagnostic claims across five tumor types including non-small cell lung, colorectal, breast, ovarian cancers and melanoma. (Approximately 50% of solid tumors based on Foundation Medicine’s volume).			Coverage across all solid tumors
Repeat Testing			No repeat testing included			Repeat testing is covered when a new primary cancer diagnosis is made by the treating physician and the patient meets other clinical criteria
Coverage with Evidence Development (CED)			Included			Removed; Coverage for FoundationOne CDx is for all solid tumors

Based on the final CMS coverage policy, FoundationOne CDx is the first and only NGS assay that presently meets the requirements of the policy, enabling national coverage for all solid tumors. For an NGS diagnostic assay to be covered under the policy, the NGS diagnostic assay must: