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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 NumberS062
Date Received11/22/2024
Decision Date05/27/2026
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT04191499
Supplement TypeNormal 180 Day 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 to include a companion diagnostic (CDx) indication for the detection of PIK3CA mutations in patients with locally advanced or metastatic breast cancer who may benefit from treatment with ITOVEBITM (inavolisib) in combination with palbociclib and fulvestrant.
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