Carlsbad, Calif.– Thermo Fisher Scientific has received FDA approval for its Oncomine Dx Express Test, a next-generation sequencing (NGS) assay that serves as a companion diagnostic for Dizal’s targeted lung cancer therapy ZEGFROVY (sunvozertinib) and for broader tumor profiling applications. The test runs on Thermo Fisher’s Ion Torrent Genexus Dx Integrated Sequencer and can deliver critical genomic results in as little as 24 hours.
This milestone marks a significant step in decentralizing precision oncology testing, allowing rapid genetic insights to be generated directly in clinical labs, closer to where patients receive care. The test is designed to detect EGFR exon 20 insertion mutations in non-small cell lung cancer (NSCLC), enabling clinicians to identify patients eligible for treatment with ZEGFROVY, a targeted therapy approved under the FDA’s accelerated approval pathway.
“NGS has transformed precision oncology, but often the turnaround time limits its clinical impact,” said Kathy Davy, President of Clinical Next-Generation Sequencing at Thermo Fisher. “With the Oncomine Dx Express Test, our goal is to give physicians fast, actionable results before treatment decisions are made.”
Beyond its use as a companion diagnostic, the test also supports comprehensive tumor profiling across 46 genes, identifying clinically relevant mutations in a variety of solid tumors. The fully automated Genexus Dx platform simplifies the NGS workflow, from sample preparation to reporting, making high-throughput sequencing more accessible to smaller labs and institutions without dedicated genomics expertise.
The assay was validated in collaboration with diagnostics company Biodesix, which will be the first lab to offer testing services using the Genexus Dx platform.
“The automation of this system has the potential to significantly streamline our lab operations and cut down turnaround time from sample receipt to report generation,” said Gary Pestano, Ph.D., Chief Development Officer at Biodesix.
ZEGFROVY, developed by Dizal, was granted accelerated FDA approval following Breakthrough Therapy and Priority Review designations. It is currently the only approved EGFR tyrosine kinase inhibitor specifically targeting exon 20 insertion mutations—a rare and hard-to-treat form of NSCLC.
“The approval of this companion diagnostic allows more patients to be rapidly identified and matched to ZEGFROVY,” said Susan Chen, Senior Vice President of Clinical Operations at Dizal. “This represents a critical advancement for patients with a particularly aggressive form of lung cancer.”
With this FDA approval, Thermo Fisher continues to expand its role in advancing personalized medicine, enabling faster, more precise, and more widely accessible cancer care.
