FoundationOne CDx, FoundationOne Liquid CDx
by Foundation Medicine, Inc. PMA
Active
PMA P170019
Overview
FoundationOne CDx is a next-generation sequencing in vitro diagnostic device designed for detecting genomic alterations, including substitutions, insertions, deletions, copy number alterations, microsatellite instability (MSI), and tumor mutational burden (TMB). It analyzes DNA from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens or liquid biopsy samples to identify mutations in 324 genes and select gene rearrangements, supporting precision oncology diagnostics.
The FoundationOne CDx assay is performed as a single-site test at Foundation Medicine, Inc., and is intended for use as a companion diagnostic to guide treatment selection for targeted therapies in specific cancers, such as non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer. It is supplied as a laboratory-based diagnostic tool and is regulated under FDA Premarket Approval (PMA) with PMA number P170019.
Regulatory status
Recall ongoing. 7 ongoing FDA recalls. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP170019 | Date30 Nov 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
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- Ongoing Z-2951-2026
Software issue that can cause an increase in spontaneous software closures.
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- Ongoing Z-1937-2026
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
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- Ongoing Z-1927-2026
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
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- Ongoing Z-1747-2025
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
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- Ongoing Z-1890-2025
Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
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- Ongoing Z-1891-2025
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
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- Ongoing Z-0577-2026
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
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- Terminated Z-0535-2020
Identified potential false positive MSI-H on the test reports provided to the physicians.
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- Terminated Z-0649-2019
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
Specification
- Trade Name
- FoundationOne CDx
- Generic Name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- PMA Number
- FDA Product Code
- PQP
- Device Class
- Class III
- Advisory Committee
- Pathology
- FDA Decision
- APPR Approved
Other devices from Foundation Medicine, Inc.
Questions
How is the FoundationOne CDx test performed, and where can it be ordered from?
The FoundationOne CDx test is performed as a **single-site assay exclusively at Foundation Medicine, Inc.** in Boston, Massachusetts. It requires DNA extracted from either formalin-fixed paraffin-embedded (FFPE) tumor tissue or liquid biopsy samples. Clinicians or laboratories do not perform the test in-house; instead, they submit eligible specimens to Foundation Medicine for analysis. The assay is designed to be used as a companion diagnostic to guide treatment decisions for specific cancers, such as non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer.
What types of genomic alterations does the FoundationOne CDx test detect, and how many genes are analyzed?
The FoundationOne CDx test uses **next-generation sequencing** to detect a broad range of genomic alterations, including **substitutions, insertions, deletions, copy number alterations (CNAs), microsatellite instability (MSI), and tumor mutational burden (TMB)**. It analyzes DNA from **324 genes** and select gene rearrangements, providing comprehensive mutation profiling for precision oncology diagnostics.
Is the FoundationOne CDx test approved for use in guiding treatment for multiple cancer types, and if so, which ones?
Yes, the FoundationOne CDx test is **FDA-PMA approved** as a companion diagnostic to help guide treatment selection for targeted therapies in **five specific cancer types**: non-small cell lung cancer (NSCLC), melanoma, breast cancer, colorectal cancer, and ovarian cancer. The test identifies biomarkers linked to approved therapies, such as EGFR mutations for NSCLC (e.g., afatinib, osimertinib) or BRCA1/2 alterations for ovarian cancer (e.g., rucaparib). It also supports broader tumor mutation profiling for solid malignant neoplasms under professional oncology guidelines.
What sample types can be used for the FoundationOne CDx test, and how is the assay regulated?
The FoundationOne CDx test accepts **DNA isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens or liquid biopsy samples**. The assay is regulated under **FDA Premarket Approval (PMA)** with PMA number **P170019**, ensuring its clinical validity and safety for companion diagnostic use in precision oncology. The test is not a point-of-care device but a centralized laboratory-based diagnostic tool.