In the evolving landscape of oncology, one truth is becoming increasingly clear: the right treatment at the right time can alter patient outcomes. Yet, achieving this vision of precision oncology requires tools that can keep pace with the complexity and urgency of modern cancer care.
This was the central theme of a recent webinar introducing the Ion Torrent™ Oncomine™ Dx Express Test on a Genexus™ Dx System – a solution designed to close long-standing gaps in tumor profiling and facilitate faster, more informed treatment decisions.
The precision oncology imperative
The explosion of biomarkers included in professional guidelines across multiple tumor types – lung, colorectal, breast, ovarian, and beyond – has made NGS-based genomic profiling essential. For patients with advanced or metastatic cancers, the difference between identifying the relevant biomarker and missing it could mean a missed opportunity for targeted treatment.
While traditional single-biomarker tests are valuable, they are increasingly inadequate, as well as slow, expensive, and unable to capture the full molecular complexity of tumors. Next-generation sequencing (NGS) has emerged as the clear enabler, offering broad, simultaneous biomarker analysis from a single sample, often in less time and at lower cost than serial single-gene assays.
Despite its promise, widespread NGS adoption has been hindered by significant barriers. Clinical laboratories, particularly community and hospital-based ones, face challenges including:
Lengthy validations requiring substantial time, expertise, and resources.
Financial uncertainty, with reimbursement complexities often leading to delays or out-of-pocket patient costs.
Manual, labor-intensive workflows that strain staff and prolong turnaround times.
Long time-to-results hinder clinicians’ abilities to make timely and informed decisions.
These barriers mean that clinicians often wait weeks for results, delaying critical treatment decisions.
The time to embrace NGS is now
The Oncomine Dx Express Test aims to dismantle these barriers. As an FDA-approved in vitro diagnostic solution for both companion diagnostics and tumor profiling across 46 genes, it represents a new benchmark in clinical genomics.
Key benefits include:
Rapid results: From extraction to report in as little as 24 hours.
Minimal hands-on time: Around 20 minutes, thanks to automation across nucleic purification, library prep, sequencing, and reporting.
Automated bioinformatics and reporting: It uses only one software across the whole workflow, in which you enter the samples, set up the run, and obtain the result – biomarkers classified by level of clinical significance into 3 levels, powered by the Oncomine™ Knowledgebase.
Validation done by the manufacture: There is no need for complex and time-consuming validation; any lab can implement the test after simple verification within a few weeks.
Dr David Chi from Thermo Fisher Scientific pointed out that this solution is specially designed to reduce the expertise and infrastructure burden usually associated with NGS, enabling broader access to this across laboratories of varying size and capacity, including those without previous expertise:
“The Oncomine Dx Express Test unlocks NGS for a broad spectrum of laboratories. As a validated IVD solution, labs will only need to perform a streamlined verification, which is significantly easier versus traditional validation. The automation, low hands-on time, and automated bioinformatics and reporting mean labs do not need to hire specialized labor, which may be difficult to find and costly to keep. As an IVD and CDx test, this system supports future payer coverage and reimbursement. And last, but certainly not least, this test returns results in as little as 24 hours* – allowing clinicians to make timely treatment decisions.”
From theory to practice
Early experiences from CAP/CLIA-certified laboratory Biodesix in Colorado, presented by Dr Gary Pestano, Chief Development Officer, Biodesix, underscore the technology’s impact:
“At the variance level, we saw a high degree of concordance. With 89 eligible variants out of 91, this bodes well not only for clinical testing, but for when we do our CAP proficiencies. I expect The Oncomine Dx Express Test to perform exceedingly well.”
In a concordance study of 48 formalin-fixed paraffin-embedded specimens conducted in Biodesix, the Oncomine Dx Express Test demonstrated 98 percent variant-level agreement with established multimodal assays, coupled with turnaround times as short as 24 to 48 hours.
Laboratory personnel reported strong satisfaction with automation of the workflow, saying they were “very happy with the two touch points”: reducing operator burden, and the speed with which results could be delivered. Further feedback included commentary on the “convenience for operators to have the same systems to extract and test plasma or FFPE,” and “automation of the major steps of NGS workflow, including sample purification and quantification, library preparation, sequencing, bioinformatics analysis, and reporting are very welcome!”
From the pathologist’s viewpoint, as Professor Bence Sipos, Head of Molecular pathology laboratory in Baden- Württemberg, Stuttgart, presented, the need is simple yet profound: deliver complete, clinically relevant molecular insights as quickly as possible, even from limited tissue samples. In the region served by his lab it used to take 2 to 3 weeks for oncologists in community hospitals to see NGS results. Now, he says, he can deliver them the results in as little as 2 days:
“I feel that a quiet revolution has taken place in NGS. The reliability and increased turnaround times are now comparable to other routine pathology methods. The final results are generated within 3 days in 86 percent of cases, between the weekly tumor boards, which accelerates the decision making and is optimal for patients.”
Real-world case studies presented by Bence during the webinar illustrated this imperative vividly. One example includes a 71-year-old female with a 40 year smoking history. She presented with multiple lung tumors, lymph node metastasis, and brain metastasis. The histology from the transbronchial biopsy showed pulmonary adenocarcinoma with a high PD-L1 expression: TPS 80 percent and ICS 3 percent.
“Oncologists with these results would start chemotherapy, but with the option of reliable and rapid NGS, you will have a significant impact on the course of the disease,” explains Sipos. “In this case, we were able to detect targetable biomarker in a sufficient number Aof reads with the NGS results completing on the third business day. The overall processing time – from sending the sample to reporting – was six business days.
“The patient responded well to treatment, showing a complete responses in the lung tumors and an almost complete response of the brain metastasis.” For patients with targetable biomarkers-driven non-small cell lung cancer, rapid NGS enabled timely initiation of targeted therapies, often within days of biopsy, dramatically improving treatment alignment.
A new way for oncology diagnostics
The Oncomine Dx Express Test and Genexus Dx System together mark a quiet but significant revolution: making high-quality NGS testing as accessible and routine as immunohistochemistry or polymerase chain reaction. With validated workflows, minimized turnaround times, and accessible automation, this solution has the potential to democratize precision oncology diagnostics, moving them out of elite centers and into everyday practice.
The ultimate vision, as echoed by the presenters, is a world where every patient with cancer has access to rapid, accurate, and comprehensive molecular testing, ensuring clinicians are provided with the right information to make timely treatment decisions.
For In Vitro Diagnostic Use. In US the Oncomine Express Test is indicated as a companion diagnostic (CDx) to identify non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations for treatment with EGFROVY™ (sunvozertinib) in accordance with the approved therapeutic product labeling. The Oncomine Dx Express Test detects biomarkers recommended by professional guidelines for multiple solid tumors, including substitutions, insertions, and deletions in 42 genes, copy number variants in 10 genes, and fusions or splice variants in 18 genes. For indications in other countries learn more at www.thermofisher.com/ oncomine-express-test
* Timing varies by number of samples and type of run.
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