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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
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
150 Second Street
Cambridge, MA 02141
PMA NumberP200016
Date Received03/09/2020
Decision Date11/06/2020
APCB Date 05/26/2023
Product Code PQP 
Docket Number 20M-2191
Notice Date 11/19/2020
Advisory Committee
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the FoundationOne® Liquid CDx 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 in four (4) genes, and copy number alterations in three (3) genes. 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. Table 1: Companion diagnostic indicationsTumor Type Biomarker(s) Detected TherapyNon-small cell lung cancer (NSCLC) ALK Rearrangements ALECENSA® (alectinib) EGFR Exon 19 deletions andEGFR Exon 21 L858R alteration IRESSA® (gefitinib)TAGRISSO® (osimertinib)TARCEVA® (erlotinib)Prostate cancer BRCA1, BRCA2, and ATM alterations LYNPARZA® (olaparib) BRCA1, BRCA2 alterations RUBRACA® (rucaparib)Ovarian Cancer BRCA1, BRCA2 alterations RUBRACA® (rucaparib)Breast Cancer PIK3CA mutations C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y PIQRAY® (alpelisib)Additionally, FoundationOne® Liquid CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms.A negative result from a plasma specimen does not mean that the patients 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 of the intended use statement 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 S002