PMA P200010S029

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S029
Product code: PQP
Decision date: 2026-09-18
Classification: Pathology
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order 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).

Current openFDA PMA Record#

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S029
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2026-09-18
Decision code: APPR
Date received: 2026-03-12
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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).