Thermo Fisher Scientific announced that the U.S. Food and Drug Administration has approved the Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer. The assay is now authorized as a companion diagnostic for Dizal’s ZEGFROVY and for tumor profiling in solid tumors. It delivers results in as little as 24 hours, supporting faster clinical decision-making. “With our rapid NGS solutions, we aim to deliver timely results to clinicians and their patients prior to the initiation of treatment,” said Kathy Davy, President of Clinical Next-Generation Sequencing at Thermo Fisher Scientific.
The Genexus Dx Integrated Sequencer automates the entire NGS workflow, allowing labs with limited expertise to conduct genomic testing. The Oncomine Dx Express Test also analyzes 46 genes for mutations with clinical significance. Biodesix will be the first lab to offer testing using the system. “Automation of the systems for nucleic acid purification, library preparation, sequencing and report generation has the potential to significantly improve our NGS laboratory workflows by reducing hands-on time and by delivering rapid turnaround times - from sample receipt to results,” noted Gary Pestano, Chief Development Officer at Biodesix.
