Dr Ganti on the Importance of Molecular Testing in NSCLC

“Today, in lung cancer specifically, and most cancers, understanding the molecular makeup of the tumor is very important in deciding what treatment to give the patient.”

Apar Kishor Ganti, MD, a professor in the University of Nebraska Medical Center Division of Oncology & Hematology, the Dr. and Mrs. D. Leon UMNC Research Fund Chair in Internal Medicine, and the associate director for Clinical Research at the Fred & Pamela Buffett Cancer Center, discussed the clinical implications of molecular testing results in patients with non–small cell lung cancer (NSCLC). He also highlighted the comprehensive profiling capabilities of the Oncomine DX Express Test.

Notably, on July 7, 2025, the FDA 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 patients with EGFR exon 20 insertion mutation–positive NSCLC, as well as for use in tumor profiling.

In the contemporary management of lung cancer—as well as most other malignancies—characterizing the tumor’s molecular profile is essential for guiding therapeutic decisions, Ganti began. For instance, in patients with actionable mutations, such as EGFR, ALK, or ROS1, targeted therapies constitute the first-line treatment in the metastatic setting, he stated. In earlier stages of disease, the presence of these mutations may also influence decisions regarding adjuvant therapy post-surgery, including whether to administer targeted agents like EGFR or ALK inhibitors, he explained. Additionally, identifying these mutations is crucial because immunotherapy is generally contraindicated or less effective in patients harboring certain driver mutations, according to Ganti. Thus, molecular profiling at diagnosis is critical to optimize treatment selection, he summarized.

The Oncomine Dx Express Test includes a comprehensive panel that detects all clinically actionable mutations that have approved targeted therapies, Ganti highlighted. However, this assay does not encompass every biomarker under investigation, he noted. For example, alterations like MTAP deletions are not tested for with this assay, and thus, patients with NSCLC may require additional or alternative testing to determine eligibility for certain ongoing clinical trials, he said. Nevertheless, the Oncomine Dx Express Test panel is considered sufficiently inclusive for guiding therapy with currently FDA-approved agents, he concluded.