FoundationOne Liquid CDx

FDA Premarket Approval P200016

Pre-market Approval Supplement Details

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 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 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.

DeviceFoundationOne Liquid CDx
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantFoundation Medicine, Inc.
Date Received2020-03-09
Decision Date2020-11-06
Product CodePQP 
Expedited ReviewNo
Combination Product No
Applicant Address Foundation Medicine, Inc. 150 Second Street cambridge, MA 02141

Supplemental Filings

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Supplement NumberDateSupplement Type
P200016Original Filing

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