PMA P240040

Device: Oncomine™ Dx Express Test
Applicant: Life Technologies Corporation
PMA number: P240040
Supplement: S005
Product code: PQP
Decision date: 2026-09-09
Classification: Pathology
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval to expand the indications for use to include a companion diagnostic (CDx) 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 (NSCLC) who may benefit from treatment with HYRNUO® (sevabertinib).

Current openFDA PMA Record#

Device: Oncomine™ Dx Express Test
Applicant: Life Technologies Corporation
PMA number: P240040
Supplement: S005
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2026-09-09
Decision code: APPR
Date received: 2026-03-13
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to expand the indications for use to include a companion diagnostic (CDx) 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 (NSCLC) who may benefit from treatment with HYRNUO® (sevabertinib).