Device Dossier
Oncomine™Dx Target Test
Device Dossier for Oncomine™Dx Target Test (CT929 - Acquired genetic alteration IVDs, Class 3, sponsor Thermo Fisher Scientific). ARTG record, intended…
- GMDN category: CT929 - Acquired genetic alteration IVDs
Intended purpose
The Oncomine™ Dx Target Test is a qualitative in vitro diagnostic test that uses high throughput parallel sequencing technology. It is indicated to detect sequence variations (SNVs, deletions, insertions, and fusions), in 26 cancer-related genes on DNA and RNA isolated from formalin-fixed paraffin-embedded embedded paraffin-embedded (FFPE) tissues. This test is indicated as a companion diagnostic to aid selecting non-small cell lung cancer (NSCLC) patients for treatment with the targeted therapies listed in the instructions for use in accordance with the approved therapeutic indications.
Functional description
The Oncomine™ Dx Target Test is an in vitro diagnostic next-generation sequencing test kit to detect somatic alterations in human DNA and RNA isolated from non-small cell lung cancer tumour specimens in FFPE tissue samples. Detection of these variants is performed using the Ion PGM™ Dx System. The test provides a set of primers in two panels that target key regions of multiple cancer-related genes. The kit also includes controls, RNA control diluent & an assay definition file.