Thermo Fisher Scientific has received the US Food and Drug Administration (FDA) approval for its Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer.
The next-generation sequencing (NGS) assay is designed as a companion diagnostic (CDx) for Dizal’s Zegfrovy (sunvozertinib) and for comprehensive tumour profiling.
The test generates results within 24 hours to support timely therapy decisions.
Oncomine Dx Express Test enhances the accessibility of precision oncology tools and facilitates timely decision-making in clinical environments.
Its FDA approval marks a significant advancement in decentralising NGS technology, bringing it closer to clinical settings where patients receive care.
Thermo Fisher Scientific clinical next-generation sequencing president Kathy Davy said: “NGS has been instrumental in advancing precision oncology, but these insights often aren’t available early enough to inform real-world care.
“With our rapid NGS solutions, we aim to deliver timely results to clinicians and their patients prior to the initiation of treatment.
“We’ve been leading companion diagnostics in collaboration with our pharma partners for a decade, and this approval signifies the next step in our journey bringing rapid, decentralised NGS CDx to drug development.”
The Oncomine Dx Express Test aims to streamline the NGS workflow, making precision oncology more accessible to patients globally.
Laboratories equipped with the Ion Torrent Genexus Dx Integrated Sequencer can now perform rapid genomic profiling with high accuracy in various clinical settings.
Genexus Dx Integrated Sequencer automates the entire NGS process, from sample preparation to data analysis and reporting.
It enables more laboratories, including smaller ones without prior NGS expertise, to produce timely companion diagnostic results and tumour profiling reports within 24 hours.
The Oncomine Dx Express Test specifically serves as a companion diagnostic for Zegfrovy, developed by Dizal for the treatment of patients with non-small cell lung cancer (NSCLC).
In addition, the test is approved for tumour profiling in solid tumours, detecting mutations across 46 genes with clinical significance.
Dizal senior vice president and clinical operation head Susan Chen said: “Zegfrovy is a highly effective and currently the only approved EGFR TKI targeting EGFR exon 20 insertion mutations.
“The approval of Zegfrovy will have a significant impact on platinum-pretreated patients with NSCLC harbouring EGFR exon 20 insertion mutations, a difficult-to-treat lung cancer subtype.
“Today’s FDA approval of the Oncomine Dx Express Test offers access to Zegfrovy through decentralised companion diagnostic testing.
“The ability to match patients to our therapy quickly and accurately, regardless of mutation location, can improve outcomes for this patient population.”
Biodesix, a collaborator with Thermo Fisher in validating the Oncomine Dx Express Test, will be the first laboratory to launch testing services.
The FDA approval of the Oncomine Dx Express Test enables clinicians to quickly identify eligible patients, support earlier intervention and expand access to Zegfrovy.
Biodesix chief development officer Gary Pestano said: “The Biodesix team is excited at the prospect of using the newly FDA-approved Genexus Dx Integrated Sequencer for clinical testing using the Oncomine Dx Express test and for supporting our biopharma client projects.
“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.”
