Device Dossier

Acquired genetic alteration IVDs

Device Dossier for Acquired genetic alteration IVDs (CT929 - Acquired genetic alteration IVDs, Class 3, sponsor Vela Diagnostics). ARTG record, intended…

Intended purpose

Next-Generation Sequencing (NGS) based in vitro diagnostic oncology panels that simultaneously detect hot spot mutations in various genes that have previously demonstrated clinical relevance in the management of patients with various cancer types from clinical samples. These panels are used on Sentosa SX101 in conjunction with the Sentosa ST401 and Sentosa SQ301 instruments.

TGA Public Summary