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FoundationOne Liquid CDx (F1 Liquid CDx)

by Foundation Medicine, Inc. PMA

Active United States

PMA P200006

Overview

FoundationOne Liquid CDx is a qualitative next-generation sequencing in vitro diagnostic test. It employs targeted hybridization-based capture technology to detect and report substitutions, insertions, deletions, rearrangements, and copy number alterations in 311 genes using circulating cell-free DNA (cfDNA) isolated from plasma derived from anticoagulated peripheral whole blood.

The test is performed as a single-site assay at Foundation Medicine, Inc., in Cambridge, MA. It utilizes FoundationOne Liquid CDx cfDNA blood collection tubes included in the FoundationOne Liquid CDx Blood Sample Collection Kit. Approved under an FDA PMA, this device is intended for use as a companion diagnostic to identify patients eligible for specific targeted therapies, as well as for tumor mutation profiling in oncology for solid malignant neoplasms. Sterility and single-use specifications are not explicitly stated in the provided data.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

Recall ongoing. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPCB NumberP200006 Date26 Oct 2020DecidedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2951-2026 FDA Class II initiated 10 Jun 2026

    Software issue that can cause an increase in spontaneous software closures.

    • Ongoing Z-0578-2026 FDA Class II initiated 8 Nov 2022

    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.

Specification

PMA

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
APCB

Other devices from Foundation Medicine, Inc.

Questions

  • How is the FoundationOne Liquid CDx test ordered and where is it performed?

    The FoundationOne Liquid CDx test is ordered through Foundation Medicine, Inc. and is performed exclusively at their single-site laboratory in Cambridge, Massachusetts. The test requires the use of FoundationOne Liquid CDx cfDNA blood collection tubes, which are included in the FoundationOne Liquid CDx Blood Sample Collection Kit. Since it is a single-site assay, results are generated at the manufacturer’s facility, not at the point of care or another external lab.

  • What types of blood samples are required for the FoundationOne Liquid CDx test, and how are they collected?

    The test requires circulating cell-free DNA (cfDNA) isolated from plasma derived from anticoagulated peripheral whole blood. The blood must be collected in FoundationOne Liquid CDx cfDNA blood collection tubes, which are part of the FoundationOne Liquid CDx Blood Sample Collection Kit. This ensures compatibility with the assay’s requirements for plasma processing and genomic analysis.

  • Can the FoundationOne Liquid CDx test identify patients eligible for specific targeted therapies, and if so, which cancer types and biomarkers are included?

    Yes, the FoundationOne Liquid CDx test is authorized as a companion diagnostic to identify patients eligible for targeted therapies for specific cancer types. It detects biomarkers such as EGFR exon 19 deletions and exon 21 L858R alterations, ALK rearrangements in non-small cell lung cancer (NSCLC), BRCA1/2 alterations in prostate and ovarian cancer, and PIK3CA mutations in breast cancer. These findings help guide treatment decisions for therapies like IRESSA®, TAGRISSO®, TARCEVA®, ALECENSA®, RUBRACA®, and PIQRAY®, as outlined in the approved labeling.

  • What should a clinician do if a patient tests negative for the biomarkers listed in the companion diagnostic indications?

    If a patient’s plasma specimen returns a negative result for the biomarkers listed in the companion diagnostic indications (e.g., EGFR, ALK, BRCA1/2, or PIK3CA), the test labeling advises reflexing to a routine biopsy. This means the clinician should confirm the tumor mutation status using an FDA-approved tumor tissue test, if feasible, to ensure comprehensive genomic profiling. A negative plasma result does not definitively rule out the presence of these mutations in the tumor.

  • Are there any limitations to the genomic findings reported by the FoundationOne Liquid CDx test beyond its companion diagnostic indications?

    While the test detects and reports substitutions, insertions, deletions, rearrangements, and copy number alterations in 311 genes for tumor mutation profiling, findings beyond those listed in the companion diagnostic indications (e.g., EGFR, ALK, BRCA1/2, or PIK3CA) are not prescriptive or conclusive for labeled use of any specific therapy. These additional findings may still inform clinical decision-making but should be interpreted in accordance with professional oncology guidelines rather than as direct indications for specific treatments.