Foundation Adds New Markers To FoundationOne Cancer Testing Platform
US FDA and the Centers for Medicare and Medicaid Services have already accepted FoundationOne for Parallel Review and Expedited Access for breakthrough devices. The new markers will help identify patients best-suited to immunotherapy or other targeted therarapies, the company says.
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Progress has been made in areas such as lung and breast cancer, but panelists at a recent conference noted there are many efficiencies yet to be realized in drug development and reimbursement.
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.
The head of Roche/Genentech's immuno-oncology programs discussed the firm's combination strategy at the recent American Society of Clinical Oncology annual meeting in Chicago.