PMA P160045S050

Device: Oncomine Dx Target Test
Applicant: Life Technologies Corporation
PMA number: P160045
Supplement: S050
Product code: PQP
Decision date: 2025-11-19
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 for the detection of ERBB2/HER2 activating mutations (SNVs in exons 18-21 within the tyrosine kinase domain and exon 20 insertions) in patients with non-small cell lung cancer who may benefit from treatment with HYRNUO® (sevabertinib).

Current openFDA PMA Record#

Device: Oncomine Dx Target Test
Applicant: Life Technologies Corporation
PMA number: P160045
Supplement: S050
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2025-11-19
Decision code: APPR
Date received: 2025-04-22
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 for the detection of ERBB2/HER2 activating mutations (SNVs in exons 18-21 within the tyrosine kinase domain and exon 20 insertions) in patients with non-small cell lung cancer who may benefit from treatment with HYRNUO® (sevabertinib).