Thermo Fisher Scientific’s FDA approval of the Oncomine™ Dx Express Test on the Ion Torrent™ Genexus™ Dx Integrated Sequencer marks a transformative step in democratizing access to precision oncology. As an in vitro diagnostic (IVD) and companion diagnostic (CDx), the test enables rapid next-generation sequencing (NGS) for tumor profiling and therapy selection in non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations. Uniquely designed for decentralized use, this technology combines speed and simplicity—delivering critical genomic insights in as little as 24 hours while requiring minimal hands-on time or NGS expertise.

This approval supports Dizal’s ZEGFROVY® (sunvozertinib), the only FDA-approved EGFR TKI specifically targeting exon 20 insertions, a previously hard-to-treat NSCLC subtype. With the ability to perform both CDx and tumor profiling, the Oncomine Dx Express Test empowers clinicians to identify eligible patients quickly and accurately, enabling earlier intervention and improved outcomes. Furthermore, its scalable design allows smaller labs to adopt advanced genomic testing, enhancing equity in access to precision medicine and bridging diagnostic gaps that delay treatment decisions.

The FDA’s endorsement affirms the platform’s safety, reliability, and clinical relevance, reinforcing Thermo Fisher’s leadership in NGS-based diagnostics. As real-world clinical pressures continue to mount—especially in oncology—the integration of AI-powered automation, streamlined workflows, and robust mutation coverage positions this solution as a cornerstone for modern cancer care. Ultimately, it brings us closer to the goal of delivering timely, targeted therapies to patients wherever they are, transforming how cancer is diagnosed and managed.