Partnerships Are Key To Foundation Medicine's Success
Since receiving approval for the first broad-panel diagnostic test as a combination product to detect cancer, Foundation Medicine has ramped up its partnerships with pharmaceutical companies and other stakeholders. The company expects to receive a similar approval for a broad-panel liquid biopsy genomic test in the first half of 2020.
You may also be interested in...
December 2019 Approvals Snapshot: Abbott Earns New Approval For CentriMag Circulatory Support System
December’s new medical device approvals include the FDA approval of Abbott Laboratories’ CentriMag circulatory support system for postcardiotomy patients, MicroVention’s FRED system for wide-necked intracranial aneurysms and an expanded indication for Foundation Medicine’s FoundationOne CDx cancer-drug companion diagnostic.
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.
The FoundationOne assay has been accepted into FDA's Expedited Access Pathway and the FDA/CMS Parallel Review program in an effort to advance what would be the first assay approved as a companion diagnostic for a range of tumor targets and drugs at once.