| 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. |
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| Device | FoundationOne Liquid CDx |
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| Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
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| Applicant | Foundation Medicine, Inc.
400 Summer St.
Boston, MA 02210 |
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| PMA Number | P190032 |
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| Supplement Number | S029 |
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| Date Received | 01/22/2025 |
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| Decision Date | 05/27/2026 |
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| Product Code |
PQP |
| Docket Number | FDA-6383 |
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| Notice Date | 06/04/2026 |
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| Advisory Committee |
Pathology |
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| Clinical Trials | NCT03395197
|
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval order to expand the intended use of FoundationOne Liquid CDx (F1LCDx) to include a companion diagnostic 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 Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling |
Labeling Part 2 |
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