PMA P250046
- Device
- OncoMate® MSI Dx Analysis System
- Applicant
- Promega Corporation
- PMA number
- P250046
- Product code
- SFL
- Decision date
- 2026-09-15
- Classification
- Medical Genetics
- Generic name
- Nucleic Acid Based Assay, Microsatellite Instability
- Approval order statement
- Approval for the OncoMate® MSI Dx Analysis System. The OncoMate® MSI Dx Analysis System is a qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in five microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using DNA obtained from formalin-fixed, paraffin-embedded (FFPE) solid tumor tissue. The assay requires DNA from a matched normal specimen of the same individual, which may be obtained from FFPE tissue or whole blood. The OncoMate® MSI Dx Analysis System is for use with the Applied Biosystems® 3500 Dx Genetic Analyzer and OncoMate® MSI Dx Analysis Software.The OncoMate® MSI Dx Analysis System is intended for use as a companion diagnostic to identify MSI-H patients with advanced solid tumor cancers eligible for treatment with KEYTRUDA® in accordance with the approved therapeutic product labeling.
Current openFDA PMA Record#
- Device
- OncoMate® MSI Dx Analysis System
- Applicant
- Promega Corporation
- PMA number
- P250046
- Product code
- SFL
- Generic name
- Nucleic Acid Based Assay, Microsatellite Instability
- Decision date
- 2026-09-15
- Decision code
- APPR
- Date received
- 2025-11-14
- Approval order statement
- Approval for the OncoMate® MSI Dx Analysis System. The OncoMate® MSI Dx Analysis System is a qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in five microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using DNA obtained from formalin-fixed, paraffin-embedded (FFPE) solid tumor tissue. The assay requires DNA from a matched normal specimen of the same individual, which may be obtained from FFPE tissue or whole blood. The OncoMate® MSI Dx Analysis System is for use with the Applied Biosystems® 3500 Dx Genetic Analyzer and OncoMate® MSI Dx Analysis Software.The OncoMate® MSI Dx Analysis System is intended for use as a companion diagnostic to identify MSI-H patients with advanced solid tumor cancers eligible for treatment with KEYTRUDA® in accordance with the approved therapeutic product labeling.