Oncomine™ Precision Assay GX

Oncomine™ Precision Assay GX is a targeted next-generation sequencing (NGS) assay for precision oncology research that enables rapid genomic profiling of FFPE tissue and liquid biopsy samples on the Ion Torrent™ Genexus™ System. Designed for laboratories that need fast, streamlined biomarker analysis without the complexity of traditional NGS workflows, the assay detects multiple relevant cancer variant types across 50 key genes from a single sample, with results in as little as 24 hours from specimen to report. Its automated, two-instrument workflow requires only two user touchpoints and as little as 20 minutes of hands-on time, helping laboratories expand NGS testing while conserving limited sample material and reducing operational burden.

Key features and benefits:

• Targeted precision oncology research profiling: Detects multiple relevant variant types across 50 cancer driver genes, including key biomarkers such as EGFR, ALK, BRAF, ROS1, RET, KRAS, PIK3CA, NTRK, and ERBB2. This enables meaningful genomic profiling for multiple solid tumors from a single assay.
• Rapid turnaround time (TAT): Delivers results in as little as 16 hours (from nucleic acid to report)/ 24 hours (from tissue or plasma to report). This helps laboratories deliver genomic profiling results quickly, supporting faster reporting and enabling NGS results to be combined with other biomarker testing methods such as PD-L1 by immunohistochemistry (IHC).
• Automated end-to-end workflow: Using the Integrated Genexus Sequencer together with the Genexus Purification Instrument, laboratories can go from tissue or plasma sample to report with as little as 2 touch points and 20 minutes of hands-on time. This helps improve workflow efficiency, reduce labor demands, simplify training, and lower maintenance burden.
• Low sample input requirements. The assay requires as little as 10 ng of DNA or RNA, enabling laboratories to generate results from limited samples, including fine needle aspirates (FNA).
• FFPE tissue and liquid biopsy compatibility allowing laboratories to analyse tissue when available or use plasma and other body fluids when tissue is unavailable or when concurrent liquid biopsy testing may provide additional information.

The Oncomine Precision Assay GX is optimized for use with the integrated Ion Torrent Genexus System, combining sample-to-report automation with targeted NGS content designed for solid tumor research. The workflow is run through a single software ecosystem and includes nucleic acid extraction and quantification on the Genexus Purification Instrument, followed by automated library preparation, templating, sequencing, analysis, and reporting on the Genexus Integrated Sequencer. This integrated approach helps reduce the number of manual steps and separate systems typically required for NGS, making it easier for laboratories to implement genomic profiling with fewer specialized resources and fewer new standard operating procedures.

The assay uses Ion AmpliSeq™ HD technology and requires as little as 10 ng of DNA or RNA, supporting analysis when tissue availability is limited, including small samples such as fine needle aspirates.

The panel analyzes 78 variants, including 45 mutations, 14 CNVs, and 19 fusion variants, with content curated to include established cancer drivers, resistance mutations, tumor suppressor genes such as TP53, and targets of emerging importance in precision oncology research.

The workflow is designed to be simple and automated. At the first touchpoint, the user loads the sample for nucleic acid extraction, quantification and sequencing sample plate preparation. At the second touchpoint, after loading the sample plate and consumables the Genexus Integrated Sequencer completes library preparation, templating, sequencing, and analysis, offering a report-ready result.

The workflow can support up to 16 FFPE samples for DNA and RNA based variant analysis, 32 FFPE samples for DNA-only or RNA only based variant analysis and 32 plasma samples for cfTNA based variant analysis, in one run.

Laboratories can complete up to 5 FFPE and 3 plasma runs per week.