Austin, Texas, August 3, 2026
Genprex, Inc. announced a collaboration with Roche Diagnostics to conduct biomarker assay validation studies aimed at improving patient selection for clinical trials in non-small cell lung cancer (NSCLC). The collaboration will focus on validating TROP2 as a biomarker and is intended to support a more precise approach to identifying patients who may benefit from Genprex’s oncology clinical programs. By combining Genprex’s emerging biomarker findings with Roche Diagnostics’ assay-development expertise, the companies aim to establish more refined clinical trial patient-selection criteria and advance biomarker-driven precision medicine in lung cancer.
TROP2 Biomarker Strategy Targets More Precise Patient Selection
Genprex’s previous preclinical research showed that high TROP2 H-scores and low PTEN H-scores predicted patient response, providing the scientific rationale for further biomarker validation. According to the company, these findings were subsequently correlated with longer progression-free survival (PFS) in clinical studies, particularly among NSCLC patients with TROP2 H-scores above 100 and PTEN H-scores below 100. Additional data have suggested that the intensity of TROP2 expression may also correlate with progression-free survival. Genprex is now expanding on these observations to potentially integrate TROP2 expression into patient-selection strategies for its NSCLC clinical studies. The objective is to use validated biomarker criteria to identify appropriate patients more efficiently, potentially improving clinical trial recruitment and strengthening the application of precision medicine within the company’s oncology development programs. The validation work remains an important step before TROP2-based selection can be incorporated into Genprex’s clinical strategy.
Roche Diagnostics to Perform TROP2 Assay Validation Studies
Under the collaboration, Roche Diagnostics will perform the required assay validation using its TROP2 antibody, providing Genprex with access to established diagnostic expertise and methodology. Roche Diagnostics previously received FDA Breakthrough Device Designation for an AI-driven companion diagnostic for NSCLC that uses a TROP2 score to evaluate tumor specimens. Genprex plans to use the same antibody against TROP2 for its validation studies, providing consistency with Roche’s established diagnostic approach. Genprex believes this alignment could help shorten the time required for patient identification and recruitment in future NSCLC clinical trials. The company anticipates completing the TROP2 biomarker validation studies by approximately the end of 2026, with potential integration into its NSCLC clinical program shortly thereafter, depending on the study results. The collaboration highlights the increasing role of companion diagnostics and biomarker-based patient stratification in oncology drug development, where identifying molecular and biological characteristics associated with treatment response can help sponsors design more targeted clinical development strategies.
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Biomarker Validation Supports Genprex Precision Oncology Strategy
The biomarker initiative complements Genprex’s broader development of REQORSA® Gene Therapy (quaratusugene ozeplasmid), the company’s lead oncology product candidate. REQORSA consists of a plasmid containing the TUSC2 tumor suppressor gene encapsulated within non-viral, lipid-based nanoparticles using Genprex’s proprietary Oncoprex® Delivery System. Administered intravenously, REQORSA is designed to preferentially target cancer cells and deliver a functioning TUSC2 gene while minimizing uptake by normal tissue. Genprex is currently evaluating REQORSA in clinical trials for non-small cell lung cancer and small cell lung cancer (SCLC). Both lung cancer clinical programs have received FDA Fast Track Designation, while the company’s SCLC program has also received FDA Orphan Drug Designation. The new collaboration with Roche Diagnostics adds a diagnostic and biomarker component to Genprex’s precision oncology strategy by seeking to better define which NSCLC patients may be appropriate for its clinical programs. If the validation studies successfully confirm the utility of TROP2 expression as a patient-selection biomarker, Genprex could incorporate the assay into future clinical development to refine enrollment criteria and potentially improve the efficiency of patient recruitment. The collaboration therefore represents an important intersection of gene therapy, biomarker validation, companion diagnostics and precision oncology, as Genprex works to advance targeted treatment strategies for patients with lung cancer and other diseases with significant unmet medical needs.
Source: Genprex, Roche Diagnostics press release
