FDA Clears Oncomine Dx Express Test for Sunvozertinib in EGFR Exon 20+ NSCLC

• The FDA has granted approval to the Oncomine™ Dx Express Test on the Ion Torrent™ Genexus™ Dx Integrated Sequencer as a companion diagnostic for sunvozertinib (Zegfrovy) in patients with EGFR exon 20 insertion-positive non–small cell lung cancer (NSCLC).
• The FDA’s accelerated approval of sunvozertinib was supported by data from the phase 1/2 WU-KONG trial (NCT03974022).
• The Oncomine Dx Express Test can detect EGFR exon 20 insertion mutations in tissue samples to select candidates for treatment with sunvozertinib and is designed to detect substitutions, insertions, or deletions via DNA in 42 genes, plus copy number variants in 10 genes.

The FDA has approved the Oncomine™ Dx Express Test on the Ion Torrent™ Genexus™ Dx Integrated Sequencer as a companion diagnostic for sunvozertinib, which recently received accelerated approval for patients with EGFR exon 20 insertion-positive NSCLC whose disease has progressed after platinum-based chemotherapy. The test also received a broader indication for tumor profiling across solid tumors.¹

This approval brings a rapid, decentralized next-generation sequencing (NGS) solution to community practices, offering results within 24 hours, a major shift in timely biomarker-driven care.

Sunvozertinib is now an FDA-approved option for adults with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations, a subgroup known for poor outcomes and limited treatment choices postchemotherapy.² The companion Oncomine Dx Express Test allows oncologists to quickly identify eligible patients through automated, in-house testing, without relying on centralized labs.

The platform supports testing from formalin-fixed paraffin-embedded (FFPE) tissue samples. Once loaded into the Genexus Dx system, both DNA and RNA purification and sequencing are completed in-house, allowing for same-day processing and next-day results.

“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, 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.”

Key Clinical Data

The accelerated approval of sunvozertinib was based on results from the phase 1/2 WU-KONG trial, which demonstrated a 46% overall response rate in patients treated with 200 mg of sunvozertinib once daily (95% CI, 35%-57%). The median duration of response was 11.1 months (95% CI, 8.2-not evaluable), suggesting durable clinical activity in this molecularly defined population.

The prescribing information for sunvozertinib includes warnings and precautions for interstitial lung disease/pneumonitis, gastrointestinal adverse events (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.

Expanded Utility of the Oncomine Dx Express Test

Beyond EGFR exon 20 detection, the assay is cleared for comprehensive tumor profiling, identifying actionable alterations in 46 cancer-related genes.³ It can detect:

• DNA mutations (substitutions, insertions/deletions) in 42 genes
• Copy number changes in 10 genes
• Fusions and splice variants in 18 genes (via RNA)

This expanded profiling supports broader genomic testing strategies across tumor types and may guide off-label targeted therapy or clinical trial enrollment, especially important in practices managing diverse cancer cases.

REFERENCES:

1. Thermo Fisher’s NGS assay receives FDA approval as a companion diagnostic for Zegfrovy and for tumor profiling. Thermo Fisher. News release. July 3, 2025. Accessed July 7, 2025. https://tinyurl.com/mvuenh7

2. FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. News release. US FDA. July 2, 2025. Accessed July 7, 2025. https://tinyurl.com/52k2z4z6

3. Oncomine Dx Express Test. Thermo Fisher. Accessed July 7, 2025. https://tinyurl.com/4a4dv6nj