Oncomine Dx Express Test

Abstract: 
Implementation of FDA-approved oncology next-generation sequencing (NGS) assays requires verification of performance specifications before clinical use. This presentation outlines a practical approach to analytical performance verification of the Oncomine DX Express Test, an FDA-approved assay for companion diagnostics and solid tumor profiling. Verification focuses on analytical accuracy, precision, reportable range, and reference interval using appropriately characterized specimens and acceptance criteria. Strategic sample selection is critical and should represent relevant tumor types, variant classes, tumor content, and variant allele frequencies. Compared with analytical validation of laboratory-developed tests, verification of an FDA-approved IVD does require fewer samples, shorter timelines, and lower study costs. With an appropriately designed verification strategy, Li

explained, laboratories can introduce genomic profiling into routine practice in a matter of weeks rather than many months.

Abstract: 
This presentation describes verification and implementation of Oncomine Dx Express Test with the Ion Torrent Genexus Integrated Sequencer in an independent clinical laboratory. Analytical performance was evaluated across small variants, copy number alterations, and fusions, demonstrating high concordance with reference NGS and orthogonal methods. Implementation studies confirmed analytical accuracy, precision, and reportable range, with strong performance across evaluated variant classes. For Pestano, the practical advantages extended beyond concordance metrics. His laboratory found that the automated end-to-end workflow, rapid turnaround time of less than two days, and low nucleic acid input requirements supported routine adoption in time-sensitive oncology settings. "Time to treatment is a big focus for us here at Biodesix," he affirmed.

Abstract: 
Genexus DX Software is designed to simplify and automate in-house clinical next-generation sequencing (NGS), guiding users from sample entry and run planning through analysis and clinical reporting. The software reduces the workflow to two primary user touchpoints, while sample extraction, quantification, sequencing, analysis, and application of quality control parameters are largely automated. Integrated primary and secondary analysis automatically performs base calling, read processing, alignment, variant calling, and report generation, enabling users to focus on reviewing results and generating clinical reports. Pre-established quality control thresholds, streamlined report review and secure electronic sign-off further support routine clinical use. Connectivity through application programming interfaces (APIs) also enables integration with laboratory information management systems. Wheeler concludes that simplifying software is ultimately about expanding access to precision oncology. By guiding users through standardized workflows, reducing manual intervention, and

presenting clinically actionable results in an intuitive format, integrated software can help more laboratories, and more clinicians adopt  NGS testing without requiring extensive bioinformatics expertise.

Abstract: 

Angie Cheng presented the analytical and clinical validation of the Oncomine Dx Express Test, a targeted next-generation sequencing (NGS) in vitro diagnostic assay designed for companion diagnostic (CDx) and comprehensive tumor profiling applications. The data demonstrate strong performance across limit of blank (LoB), limit of detection (LoD), reproducibility, repeatability, and analytical accuracy studies, with high agreement (>90–97%) compared to orthogonal methods and robust detection across variant types. Clinical results further support its use as a companion diagnostic for EGFR exon 20 insertions in NSCLC to guide targeted therapy selection. 

Abstract: 
Successful adoption of the Oncomine DX Express Test (ODxET) requires a clear market access pathway encompassing coding, payer coverage, and reimbursement. This presentation reviews key U.S. market access developments supporting clinical laboratories implementing ODxET. A test-specific PLA code, 0648U, becomes effective for dates of service beginning July 1, 2026, providing laboratories with a defined coding pathway. Medicare coverage is available nationally under National Coverage Determination 90.2, with early commercial payer coverage also reported. Medicare pricing is progressing through the Clinical Laboratory Fee Schedule process, with crosswalk pricing expected to begin January 1, 2027. Together, established coding, expanding coverage, evolving reimbursement, and market access resources provide laboratories with greater clarity when integrating and commercializing Oncomine Dx Express Test in the U.S. market.

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: 
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. 

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: 
See how automation and workflow design impact speed, efficiency, and cost in real‑world NGS testing.

As oncology testing demand grows, labs are under pressure to deliver accurate results faster with fewer hands and tighter budgets. In this webinar, you’ll see real time‑and‑motion data comparing two NGS workflows (amplicon- based Oncomine Dx Express Test and hybrid capture based NGS workflow) for routine precision oncology, and learn how automation can reduce touchpoints, shorten turnaround time, and support sustainable scaling. You’ll walk away with clarity on:

• Hands-on time vs turnaround time: what actually changes when workflows are redesigned
• How automation supports efficiency in precision oncology testing
• Where labs can cut bottlenecks without compromising quality
• Ways to optimize resources as testing volumes grow