Thermo Fisher Scientific, the global leader in serving science, announced today that the U.S. Food and Drug Administration (FDA) has approved the Oncomine™ Dx Express Test, running on the Ion Torrent™ Genexus™ Dx Integrated Sequencer, as an in vitro diagnostic (IVD) tool. The test is approved both as a companion diagnostic (CDx) for Dizal’s ZEGFROVY® (sunvozertinib) and for tumor profiling, marking a significant milestone in bringing fast, decentralized next-generation sequencing (NGS) to the clinical frontlines.
This FDA approval enables clinical labs, even in smaller or decentralized settings, to deliver actionable genomic insights in as little as 24 hours, enhancing timely access to precision oncology and reducing delays in treatment decision-making.
“NGS has transformed precision oncology, but actionable insights often come too late to influence treatment,” said Kathy Davy, President of Clinical Next-Generation Sequencing at Thermo Fisher. “With this approval, we’re one step closer to ensuring that critical genomic data is available to clinicians and patients before treatment decisions are made.”
Despite the transformative potential of precision medicine, many patients are unable to benefit from targeted therapies due to delayed or inaccessible genomic testing. The Oncomine Dx Express Test was specifically designed to address these gaps by simplifying the NGS workflow and making high-quality genomic profiling widely available.
Now, with the Genexus Dx platform, clinical laboratories of varying sizes can conduct rapid, automated testing—from nucleic acid extraction to sequencing and report generation—with minimal hands-on time. The platform delivers not only CDx results for ZEGFROVY, but also comprehensive tumor profiling across 46 clinically relevant genes.
ZEGFROVY (sunvozertinib), developed by Dizal, targets EGFR exon 20 insertion mutations in patients with non-small cell lung cancer (NSCLC). The companion diagnostic enables accurate identification of patients who are likely to benefit from this treatment.
Thermo Fisher has long been a leader in companion diagnostics, partnering with pharmaceutical companies for over a decade to integrate NGS into precision medicine. In this latest development, Biodesix, one of Thermo Fisher’s key collaborators, will be the first laboratory to offer clinical testing using the newly approved platform.
“We’re excited to implement the Genexus Dx Integrated Sequencer for clinical testing,” said Dr. Gary Pestano, Chief Development Officer at Biodesix. “The automation of sequencing workflows—from sample to report—greatly reduces hands-on time and enables rapid turnaround, which is critical in real-world oncology care and drug development.”
By streamlining complex genomic workflows into a single, automated platform, Thermo Fisher’s Genexus Dx system enables broader access to precision diagnostics. This advancement is poised to enhance patient outcomes by providing clinicians with timely, actionable insights that guide treatment before therapy begins.