In a move aimed at broadening access to precision cancer treatment, the U.S. Food and Drug Administration has approved a new diagnostic test developed by Thermo Fisher Scientific. The Oncomine Dx Express Test, used with the Ion Torrent Genexus Dx Integrated Sequencer, has been cleared for use as a companion diagnostic to identify patients eligible for ZEGFROVY (sunvozertinib), a targeted therapy from Dizal, as well as for broader tumor profiling in solid tumors.
The approval allows clinical laboratories, including those outside major research hospitals, to conduct next-generation sequencing (NGS) in a more streamlined and time-efficient manner. The platform enables genomic profiling results in as little as 24 hours, which could reduce delays in treatment planning for patients with non-small cell lung cancer (NSCLC).
ZEGFROVY was granted FDA accelerated approval for treating NSCLC patients whose tumors carry EGFR exon 20 insertion mutations, a relatively rare and hard-to-treat subset of lung cancer. The Oncomine Dx Express Test is now an approved tool to detect these mutations and identify candidates for the therapy.
The FDA’s decision also extends the test’s use to tumor profiling across 46 genes in solid tumors, offering clinicians data on genetic alterations with known or potential clinical significance. The platform automates the entire sequencing process, from sample preparation to reporting, reducing the need for extensive laboratory infrastructure or specialized staff.
Industry observers note that slow or inaccessible genomic testing has historically limited the reach of precision oncology. Faster turnaround times could help more patients access appropriate therapies without delays caused by outsourcing testing to central labs.
Biodesix, a molecular diagnostics company that collaborated with Thermo Fisher in the test’s validation, will be the first lab to offer testing services using the new system.
The Genexus Dx system is part of a broader trend toward decentralizing molecular diagnostics. By moving testing capabilities closer to the point of care, developers aim to close gaps in access and reduce the time between diagnosis and treatment.