Oncomine Dx Express Test

Abstract: 
David Chi presented the newly FDA-approved Oncomine™ Dx Express Test (ODxET)—a comprehensive next-generation sequencing (NGS) solution for solid tumor profiling and companion diagnostics. The presentation highlighted the test’s ability to analyze 46 genes across DNA and RNA, including EGFR exon 20 insertion as a CDx indication. Built on the Genexus™ Dx Integrated Sequencer, the test delivers results in as little as 24 hours with only ~20 minutes of hands-on time, significantly simplifying NGS implementation for community and hospital laboratories. With automated workflow, flexible multiplexing, and payer-aligned validation, the ODxET addresses key barriers to NGS adoption—turnaround time, cost, complexity, and staffing—enabling rapid, reliable biomarker-driven treatment decisions. 

Abstract: 
Gary Pestano of Biodesix shared their real-world experience evaluating the Oncomine Dx Express Test and Genexus Dx System in a CAP/CLIA-certified laboratory setting. Using 48 FFPE samples, the team demonstrated 98% variant-level concordance compared to a validated reference NGS assay, underscoring the test’s accuracy and reproducibility. Laboratory staff praised the system’s end-to-end automation, dual-touch workflow, and ability to process up to 12 samples per run with rapid 24–48-hour turnaround. Feedback emphasized major workflow efficiencies—from automated extraction to integrated bioinformatics reporting—making ODxET a practical and scalable solution for molecular diagnostics laboratories seeking to expand NGS capabilities.

Abstract: 
Prof. Bence Sipos shared practical, pathology-centered insights into adopting rapid NGS for oncology testing. He discussed the growing clinical need for comprehensive molecular characterization from minimal FFPE samples and highlighted the Oncomine Dx Express Test as a solution balancing speed, sensitivity, and sample efficiency. His laboratory in Stuttgart performed ~5,000 NGS tests annually, achieving ≤3-day turnaround in over 80% of cases and <1% drop-off rate. Case studies in NSCLC and other solid tumors illustrated ODxET’s diagnostic value in guiding timely targeted therapy decisions. Dr. Sipos concluded that rapid, reliable NGS is now equivalent in turnaround and dependability to traditional pathology methods like IHC—representing a “quiet revolution” in molecular diagnostics.