PMA P200010S027

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S027
Product code: PQP
Decision date: 2026-06-10
Classification: Pathology
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval to include a companion diagnostic indication to identify patients with non-small cell lung cancer (NSCLC) harboring ERBB2/HER2 activating mutations (SNVs in exons 18-21 within the tyrosine kinase domain and exon 20 insertions) who are eligible for treatment with HERNEXEOS (zongertinib).

Current openFDA PMA Record#

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S027
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2026-06-10
Decision code: APPR
Date received: 2025-11-13
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to include a companion diagnostic indication to identify patients with non-small cell lung cancer (NSCLC) harboring ERBB2/HER2 activating mutations (SNVs in exons 18-21 within the tyrosine kinase domain and exon 20 insertions) who are eligible for treatment with HERNEXEOS (zongertinib).