PMA P190031S015

Device: HER2 Dual ISH DNA Probe Cocktail
Applicant: Ventana Medical Systems, Inc.
PMA number: P190031
Supplement: S015
Product code: NYQ
Decision date: 2026-05-15
Classification: Pathology
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Approval order statement: Approval to include HER2 Dual ISH DNA Probe Cocktail as a companion diagnostic indication for the determination of HER2 gene amplification status in patients with breast cancer who may benefit from treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki).

Current openFDA PMA Record#

Device: HER2 Dual ISH DNA Probe Cocktail
Applicant: Ventana Medical Systems, Inc.
PMA number: P190031
Supplement: S015
Product code: NYQ
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Decision date: 2026-05-15
Decision code: APPR
Date received: 2025-08-15
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to include HER2 Dual ISH DNA Probe Cocktail as a companion diagnostic indication for the determination of HER2 gene amplification status in patients with breast cancer who may benefit from treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki).