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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceFoundationOne Liquid CDx (F1 Liquid CDx)
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine Inc.
150 Second Street
Cambridge, MA 02141
PMA NumberP190032
Date Received12/26/2019
Decision Date08/26/2020
Product Code PQP 
Docket Number 20M-1821
Notice Date 09/01/2020
Advisory Committee Pathology
Clinical TrialsNCT01891344
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the FoundationOne® Liquid CDx. The device is a qualitative next generation sequencing based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology to detect and report substitutions, insertions and deletions (indels) in 311 genes, including rearrangements and copy number losses only in BRCA1 and BRCA2. FoundationOne® Liquid CDx utilizes circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of cancer patients collected in FoundationOne® Liquid CDx cfDNA blood collection tubes included in the FoundationOne® Liquid CDx Blood Sample Collection Kit. The test is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling. Additionally, FoundationOne® Liquid CDx is intended to provide tumor mutation profiling for substitutions and indels to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Table 1: Companion diagnostic indicationsTumor Type Biomarker(s) Detected TherapyNon-small cell lung cancer (NSCLC) EGFR exon 19 deletions andEGFR exon 21 L858R alteration IRESSA® (gefitinib)TAGRISSO® (osimertinib)TARCEVA® (erlotinib)Prostate cancer BRCA1, BRCA2 alterations RUBRACA® (rucaparib)A negative result from a plasma specimen does not mean that the patient’s tumor is negative for genomic findings. Patients who are negative for the mutations listed in Table 1 should be reflexed to routine biopsy and their tumor mutation status confirmed using an FDA-approved tumor tissue test, if feasible.Genomic findings other than those listed in Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product. FoundationOne® Liquid CDx is a single-site assay performed at Foundation Medicine, Inc. in Cambridge, MA.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 S010 S011 S013 
S018 S020