Guardant360 CDx
Guardant Health, Inc. · Next generation sequencing oncology panel, somatic or germline variant detection system · Pathology
Open FDA's page for this record- PMA number
- P200010
- Supplement number
- S029
- Applicant
- Guardant Health, Inc.
- Street 1
- 505 Penobscot Dr.
- City
- Redwood City
- State
- CA
- Zip
- 94063
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Trade name
- Guardant360 CDx
- Product code
- PQP
- Advisory committee
- PA
- Advisory committee description
- Pathology
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited review flag
- N
- Date received
- 2026-03-12
- Decision date
- 2026-09-18
- Decision code
- APPR
- Ao statement
Approval for expanding the intended use and indications for use of Guardant360 CDx to include a companion diagnostic indication for the detection of ESR1 mutations in Breast Cancer (BC) patients who may benefit from treatment with INLURIYO (imlunestrant) in combination with VERZENIO (abemaciclib).
- Harmonized identifiers (openFDA)
- Device name
- Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3017020141, 3013200421, 3003335080, 3010679023, 3010889807, 3031598391, 3012090384, 3030654068, 3011104381, 3003218906, 3020703032, 3007287152
- FEI number
- 3013200421, 3003335080, 3010679023, 3010889807, 3016560486, 3031598391, 3012090384, 3030654068, 3008335090, 3011104381, 3003218906, 3007287152