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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 (F1CDx)
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
400 Summer St.
Boston, MA 02210
PMA NumberP170019
Supplement NumberS060
Date Received09/20/2024
Decision Date05/27/2026
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT03395197
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval order to expand the intended use of FoundationOne CDx (F1CDx) to include a companion diagnostic (CDx) indication for the detection of HRR gene alterations (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, RAD51C) in patients with metastatic castrate-resistant prostate cancer (mCRPC) who may benefit from treatment with TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
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