PMA P160045S049

Device: Oncomine Dx Target Test
Applicant: Life Technologies Corporation
PMA number: P160045
Supplement: S049
Product code: PQP
Decision date: 2025-08-08
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 in the tyrosine kinase domain (SNVs in exons 18-21 and exon 20 insertions) who are eligible for treatment with HERNEXEOS (zongertinib).

Current openFDA PMA Record#

Device: Oncomine Dx Target Test
Applicant: Life Technologies Corporation
PMA number: P160045
Supplement: S049
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2025-08-08
Decision code: APPR
Date received: 2024-12-17
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 in the tyrosine kinase domain (SNVs in exons 18-21 and exon 20 insertions) who are eligible for treatment with HERNEXEOS (zongertinib).