FDA Approves Oncomine Dx Express Test for Tumor Profiling and as Companion Diagnostic for Sunvozertinib in NSCLC

FDA

The FDA has approved the 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 sunvozertinib (Zegfrovy) in EGFR exon 20 insertion mutation–positive non–small cell lung cancer (NSCLC) and for use in tumor profiling.1

On July 2, 2025, the FDA granted accelerated approval to sunvozertinib for the treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.2

Beyond its approval as a companion diagnostic for sunvozertinib, the Oncomine Dx Express Test is also indicated for tumor profiling in solid tumors and the detection of cancer mutations with evidence of clinical significance and potential clinical significance across 46 genes.1

The tumor profiling approval allows for rapid next-generation sequencing (NGS) in a decentralized clinical setting, with results produced in as little as 24 hours.

“NGS has been instrumental in advancing precision oncology, but these insights often aren’t available early enough to inform real-world care,” Kathy Davy, president of Clinical Next-Generation Sequencing at Thermo Fisher Scientific, stated in a news release. “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 [a] rapid, decentralized NGS companion diagnostic to drug development. We are proud of our collaboration with Dizal to bring [sunvozertinib] to the US market.”

Oncomine Dx Express can detect EGFR exon 20 insertion mutations in tissue samples to select candidates for treatment with sunvozertinib.3 The test is also designed to detect substitutions, insertions, or deletions via DNA in 42 genes, plus copy number variants in 10 genes. It can also detect fusions and splice variants in 18 genes via RNA.

After the patient sample is collected, the pretreated formalin-fixed paraffin–embedded tissue is loaded into the Genexus Dx Purification System, which performs automated DNA and RNA purification and quantification. The purified sample is then placed in the Genexus Dx Integrated Sequencer on the same day, and results are available the following day.

Diving into the Sunvozertinib Approval

The FDA’s accelerated approval of sunvozertinib was supported by data from the phase 1/2 WU-KONG trial (NCT03974022), which showed that in patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations who experienced disease progression on or after platinum-based chemotherapy, sunvozertinib given at 200 mg once per day (n = 85) produced an overall response rate (ORR) of 46% (95% CI, 35%-57%).2 Patients experienced a median duration of response (DOR) of 11.1 months (95% CI, 8.2-not evaluable).

Investigators enrolled patients at least 18 years of age with histologically or cytologically confirmed, locally advanced or metastatic NSCLC harboring EGFR or HER2 mutations who had received 1 to 3 lines of therapy in the metastatic/locally advanced setting.4 Patients needed to have an ECOG performance status of 0 to 1, a life expectancy of at least 12 weeks, measurable disease per RECIST 1.1 criteria, and adequate organ system function. Those with brain metastases were allowed to enroll if they were previously treated and stable, neurologically asymptomatic, and did not require corticosteroids.

Sunvozertinib was evaluated as a single agent during the dose-escalation and -expansion study. Safety and tolerability was the primary end point of part A; ORR per RECIST 1.1 criteria served as the primary end point in part B.

The prescribing information for sunvozertinib includes warnings and precautions for interstitial lung disease /pneumonitis, gastrointestinal adverse effects (AEs), dermatologic AEs, ocular toxicity, and embryo-fetal toxicity.2 Sunvozertinib is recommended at a dose of 200 mg once per day with food until disease progression or unacceptable toxicity.

References

1. Thermo Fisher’s NGS assay receives FDA approval as a companion diagnostic for Zegfrovy and for tumor profiling. Thermo Fisher. July 3, 2025. Accessed July 7, 2025. https://newsroom.thermofisher.com/newsroom/press-releases/press-release-details/2025/Thermo-Fishers-NGS-Assay-Receives-FDA-Approval-as-a-Companion-Diagnostic-for-ZEGFROVY-and-for-Tumor-Profiling/default.aspx
2. FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. FDA. July 2, 2025. Accessed July 7, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20
3. Oncomine Dx Express Test. Thermo Fisher. Accessed July 7, 2025. https://www.thermofisher.com/us/en/home/clinical/diagnostic-testing/condition-disease-diagnostics/oncology-diagnostics/oncomine-dx-express-test-ngs-us.html
4. Assessing an oral EGFR inhibitor, sunvozertinib in patients who have advanced non-small cell lung cancer with EGFR or HER2 Mutation (WU-KONG1). ClinicalTrials.gov. Updated February 28, 2025. Accessed July 7, 2025. https://clinicaltrials.gov/study/NCT03974022