AI devices with FDA product code PZM — Next Generation Sequencing Based Tumor Profiling Test

Product code PZM (“Next Generation Sequencing Based Tumor Profiling Test” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Pathology panel (1). The most recent decision was GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) on August 29, 2025.