FDA OKs New Test to Match Lung Cancer Patients With Targeted Therapies

The U.S. FDA has approved a new test for patients with lung cancer to match the correct individuals with a targeted treatment called Zegfrovy.

The U.S. Food and Drug Administration (FDA) has approved a new test for patients with lung cancer to match the correct individuals with a targeted treatment called Zegfrovy (sunvozertinib), according to a news release from Thermo Fisher Scientific.

This test is referred to as a companion diagnostic and helps healthcare professionals understand whether patients may be a good fit for Zegfrovy treatment in as little as 24 hours and assists with timely therapeutic decisions. The test, called the Oncomine™ Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer, can also be used in tumor profiling. Tumor profiling is a method used in the laboratory which evaluates patient's tumor tissue or blood to identify genetic and molecular characteristics that are driving the cancer's growth, according to the Fox Chase Cancer Center website.

Specifically, the test is now approved for patients with non-small cell lung cancer (NSCLC) whose disease harbor EGFR exon 20 insertion mutations and are therefore eligible for treatment with Zegfrovy. Additionally, the tumor profiling portion of the approval provides potential due to its ability to detects cancer mutations across 46 genes.

The approval of the Oncomine Dx Express Test is important because of its speed, as it provides results in as little as 24 hours, moving the needle in the field of rapid next-generation sequencing.

Next-generation sequencing is a type of technology that is used to study genetic mutations in the DNA or RNA which are affecting the state of the disease, in this case cancer, according to an article from Thermo Fisher Scientific, which stated that the method was first introduced commercially in 2005.

“Next-generation sequencing 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 next-generation sequencing 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 next-generation sequencing CDx to drug development. We are proud of our collaboration with Dizal to bring Zegfrovy to the U.S. market.”

The makeup of each patient’s tumor is different and has the potential to guide their cancer care. However, test result delays can result in missed opportunities to make informed decisions and can even cause doctors to pass on targeted therapies, which typically have the potential for more curative outcomes. This greatly impacts the efficacy of the treatment and patient outcomes.

Moreover, patients also miss out on targeted therapies they may be eligible for due to inefficiencies or lack of access to testing. This is why timely and accurate genetic testing is important, creating an unmet need in the treatment space.

To address these unmet needs, the Oncomine Dx Express Test aims to simplify the workflow of next-generation sequencing and connect eligible patients to precision oncology. With this new system, laboratories can deliver rapid answers with exceptional accuracy and ease, helping doctors make faster and more informed treatment decisions.

“[This approval] … has the potential to significantly improve our next-generation sequencing laboratory workflows by reducing hands-on time and by delivering rapid turnaround times — from sample receipt to results,” said Dr. Gary Pestano, chief development officer at Biodesix.

More Information on Zegfrovy

The news release concluded by sharing details on the use of Zegfrovy.

“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,” said Susan Chen, senior vice president, head of clinical operation at Dizal. “Today’s FDA approval of the Oncomine Dx Express Test offers access to Zegfrovy through decentralized 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.”

The agent was initially granted accelerated approval from the FDA after receiving both a breakthrough therapy designation and priority review for patients with NSCLC whose disease has EGFR exon 20 insertion mutations.

With the regulatory approval of the Oncomine Dx Express Test both as a companion diagnostic and in tumor profiling, healthcare professionals can now quickly identify eligible patients for treatment, getting them access to this targeted therapy more quickly, the news release said.

References:

• "Thermo Fisher’s NGS Assay Receives FDA Approval as a Companion Diagnostic for ZEGFROVY and for Tumor Profiling." News release. Thermo Fisher Scientific. July 3, 2025.
• "What is Next-Generation Sequencing (NGS) Technology?" Thermo Fisher Scientific.

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