Oncomine™ Dx Express Test Panel

The Ion Torrent Oncomine Dx Express Test Panel contains the set of oligos that when used with the required instruments and consumables allow for the following intended use:

FFPE samples
The Oncomine Dx Express Test is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing (NGS) technology to detect deletions, insertions, substitutions, and copy number gain present in 42 genes and fusions in 18 genes from DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples. The Oncomine Dx Express Test is for use with the Genexus Dx System.

The Oncomine Dx Express Test is intended to provide clinically relevant tumor mutation profiling information to be used by qualified health care professionals in accordance with professional guidelines as an aid in therapy management of cancer patients with solid malignant neoplasms. It is not conclusive or prescriptive for labeled use of any specific therapeutic product.

Plasma samples
The Oncomine Dx Express Test is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing (NGS) technology to detect deletions, insertions, and substitutions in 42 genes and fusions in 7 genes from cfTNA extracted from plasma samples. The Oncomine Dx Express Test is for use with the Genexus Dx System.

The Oncomine Dx Express Test is intended to provide clinically relevant tumor mutation profiling information to be used by qualified health care professionals in accordance with professional guidelines as an aid in therapy management of cancer patients with non-small cell lung cancer. It is not conclusive or prescriptive for labeled use of any specific therapeutic product.

Additional products that are required to complete the Oncomine Dx Express Test workflow include:
• Genexus Dx Integrated Sequencer
• Genexus Dx Library Strips 1 and 2-HD
• Genexus Dx Templating Strips 3-GX5 and 4
• Genexus Dx Sequencing Kit
• Genexus Dx Barcodes 1-32 HD
• Genexus Dx GX5 Chip and Genexus Coupler
• Genexus Dx Pipette Tips
• Oncomine Express Test FFPE DNA and RNA Control Kit
• Oncomine Express Test Plasma cfTNA Control Kit
• MicroAmp EnduraPlate Optical 96-Well Clear GPLE Reaction Plates with Barcode
• Thermo Scientific Adhesive PCR Plate Foils