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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceFoundationOne CDx
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
150 Second Street, 1st Floor
Cambridge, MA 02141
PMA NumberP170019
Supplement NumberS015
Date Received12/16/2019
Decision Date05/19/2020
Product Code PQP 
Docket Number 20m-1420
Notice Date 05/27/2020
Advisory Committee Pathology
Clinical TrialsNCT02987543
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to expand the intended use of FoundationOne®CDx to include a companion diagnostic indication for homologous recombination repair (HHR) gene alterations in patients with metastatic castration resistant prostate cancer who may benefit from treatment with Lynparza®(olaparib).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness