FoundationOne® CDx by Foundation Medicine

Foundation Medicine, Inc.

FoundationOne® CDx by Foundation Medicine

FoundationOne CDx is the first FDA-approved tissue-based broad companion diagnostic (CDx)

FDA Breakthrough Device Designation

Do you know anyone using FoundationOne® CDx by Foundation Medicine?

FoundationOne CDx is a tissue-based companion diagnostic (CDx) that has been clinically and analytically validated for all solid tumors, and has been approved by the FDA. The test provides physicians with clinically actionable information, including information on appropriate therapies and evidence of resistance, based on the individual genomic profile of a patient’s cancer. The test results include microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions, and loss of heterozygosity (LOH) for ovarian cancer patients. Additionally, there is an option to order PD-L1 immunohistochemistry (IHC) testing as an optional add-on test. If the tissue submitted does not meet the criteria for successful testing, the option to reflex from FoundationOne CDx testing to FoundationOne®Liquid CDx is available. FoundationOne CDx also has national coverage for qualifying Medicare and Medicare Advantage patients across all solid tumors.

FoundationOne® CDx by Foundation Medicine

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