The U.S. Food and Drug Administration has approved Thermo Fisher Scientific's Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer as an in vitro diagnostic assay for use as a companion diagnostic for Dizal's ZEGFROVY (sunvozertinib) and in tumor profiling. This approval brings rapid next-generation sequencing to decentralized clinical settings closer to where patients receive care, with the ability to deliver essential genomic insights in as little as 24 hours.
Addressing Critical Gaps in Precision Oncology
The approval addresses a significant challenge in precision oncology care. According to the announcement, delays in obtaining genomic profiling results can hinder clinicians' ability to make informed decisions, potentially causing patients to miss out on targeted therapies, which can impact treatment efficacy and patient outcomes. Furthermore, a significant number of patients miss out on targeted therapies due to inefficiencies or lack of access to testing, highlighting the critical role of timely genomic profiling.
The Oncomine Dx Express Test was specifically designed to simplify the NGS workflow and connect patients everywhere to precision oncology. With this approval, 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.
Companion Diagnostic for ZEGFROVY
The Oncomine Dx Express Test is intended for use as a companion diagnostic for ZEGFROVY (sunvozertinib), a targeted therapy from Dizal, to identify patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. In addition, the test has been approved for tumor profiling in solid tumors and detects cancer mutations with evidence of clinical significance and potential clinical significance across 46 genes.
ZEGFROVY, developed by Dizal, was granted FDA accelerated approval following Breakthrough Therapy designation and Priority Review for the treatment of NSCLC patients with EGFR exon 20 insertion mutations. According to Susan Chen, senior vice president and head of clinical operation at Dizal, "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 harboring EGFR exon 20 insertion mutations, a difficult-to-treat lung cancer subtype."
Automated NGS Technology for Broader Access
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 enables laboratories to generate timely companion diagnostic 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. 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, decentralized NGS CDx to drug development."
First Laboratory Implementation
Biodesix, one of Thermo Fisher's collaborators in the validation of Oncomine Dx Express Test on the Genexus Dx Integrated Sequencer, will be the first lab to launch testing services. Gary Pestano, Ph.D., chief development officer at Biodesix, noted that "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."
The approval represents a significant advancement in making precision oncology more accessible and timely, particularly for patients with NSCLC harboring EGFR exon 20 insertion mutations, who previously had limited treatment options. With the companion diagnostic now available, clinicians can quickly identify eligible patients, supporting earlier intervention and expanding access to targeted therapy.
