Genprex and Roche Collaborate on AI-Driven NSCLC Biomarker Testing

Assay validation and clinically meaningful thresholds are critical to enrolling the right patients and interpreting outcomes. A new collaboration now aims to validate TROP2-based biomarker assays to refine patient selection in non-small cell lung cancer studies.

Genprex has entered a collaboration with Roche Diagnostics to conduct biomarker assay validation studies supporting patient selection for non-small cell lung cancer (NSCLC) clinical trials. The initiative centers on TROP2 and will use the same validated TROP2 antibody across assay validation and subsequent studies to ensure consistency. Genprex reports that its initial research linked high TROP2 H-scores and low PTEN H-scores to response in preclinical work, with corresponding associations to longer progression-free survival in clinical settings.

Within the datasets cited, longer progression-free survival was observed among NSCLC patients with TROP2 H-scores above 100 and PTEN H-scores below 100, offering a potential framework for stratification in future trials. Additional data indicate that the intensity of TROP2 expression may correlate with progression-free survival. The validation work is intended to optimize these criteria and accelerate identification and recruitment of eligible participants.

Roche Diagnostics has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for what it describes as the first AI-driven companion diagnostic for NSCLC that uses a TROP2 score to evaluate tumor specimens. Under the collaboration, Roche will perform the necessary assay validation using its TROP2 antibody, and Genprex will employ the same antibody in its studies. Genprex anticipates completing the validation studies by approximately the end of 2026, with potential integration into its NSCLC clinical program thereafter depending on the results.

“This strategic partnership with Roche Diagnostics, a recognized leader in NSCLC assay development and the recipient of an FDA Breakthrough Device Designation for their AI-driven TROP2 diagnostic, is a testament to our shared commitment to advancing precision treatments in oncology,” said Ryan Confer, President and Chief Executive Officer at Genprex.

“By utilizing the same validated TROP2 antibody that Roche has used in other studies, we are poised to shorten the time for patient identification and recruitment for NSCLC clinical trials, ultimately delivering more effective, personalized treatment options,” added Confer.