- Cancer Type
- Sample Type
- Results Expected
What is FoundationOne CDx?
FoundationOne CDx is the first FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors. The test is designed to provide physicians with clinically actionable information — both to consider appropriate therapies for patients and understand results with evidence of resistance — based on the individual genomic profile of each patient’s cancer. Every test result includes microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions. You can also order PD-L1 immunohistochemistry (IHC) testing† to help inform your therapy decision.
FoundationOne CDx will be available to order in early 2018 upon completion of the Parallel Review process with FDA and CMS.
FDA-approved targeted therapies
- A single test that looks for all guideline-recommended genes in solid tumors, including CDx indications with a direct path to therapy.
- Results include MSI and TMB with the option to add PD-L1† testing to help inform immunotherapy decisions.
- Comprehensive platform that can be updated regularly as more genes and genomic signatures are indicated for use with FDA-approved therapies.
Go Beyond FoundationOne®
Now with Clinical Validation
FoundationOne CDx is the next evolution of FoundationOne®, our pioneering laboratory-developed test (LDT).
FoundationOne CDx is approved by the FDA and has been clinically and analytically validated with 9 times more samples and cell lines as compared with our analytical validation of FoundationOne.
The first FDA-approved broad companion diagnostic
FoundationOne CDx provides comprehensive results with a FFPE tissue block or 10 slides (and 1 H&E slide) to save tissue and time compared to sequential single-marker tests.