On July 3, 2025, FDA approved a new rapid tumor panel platform from Thermo Fisher, the Oncomine Dx Express Test. The product runs on the Ion Torrent Genexus sequencing system. Depending on the number of samples, results may be returned in as little as 24 hours. For details see the Thermo Fisher press release here.
The labeling has two scenarios, as a CDx for ZEGFROVY (sunvozertinib, EGFR Exon 20), and, in gene profiling of solid tumors. Find the home page for Oncomine Dx Express Test here.
Thermo Fisher writes,
- The Oncomine Dx Express Test was designed to simplify the NGS workflow and connect patients everywhere to precision oncology.
- Now with the Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer, laboratories across a variety of clinical settings can deliver rapid genomic profiling with exceptional accuracy and ease, helping to ensure patients can benefit from the latest advancements in precision oncology.
- The Genexus Dx Integrated Sequencer automates the NGS workflow — from sample preparation to data analysis and reporting — making the technology accessible to more laboratories, including those that are smaller and without previous NGS expertise. It also enables laboratories to generate timely CDx results as well as tumor profiling reports in as little as 24 hours, helping accelerate insights and access to precision oncology.
- “NGS has been instrumental in advancing precision oncology, but these insights often aren’t available early enough to inform real-world care,” said Kathy Davy, president of Clinical Next-Generation Sequencing at Thermo Fisher Scientific. “With our rapid NGS solutions, we aim to deliver timely results to clinicians and their patients prior to the initiation of treatment."
Reported genetic results are in table (click to enlarge). Columns include copy number variants and fusion/splice variants.
