PREDAPT Trial Validates RNA-Based Predictive Biomarker Across 1400+ Patients to Inform Immunotherapy Treatment in NSCLC
Cofactor Genomics, a leader in cancer immunotherapy predictive diagnostics, today announced results from the PREDAPT non-small cell lung cancer (NSCLC) trial validating the company’s OncoPrism-NSCLC test. OncoPrism-NSCLC is powerful clinical tool to identify which patients with late stage NSCLC are most likely to benefit from immune checkpoint inhibitor (ICI) therapy—enabling more precise, timely, and cost-effective treatment strategies in oncology.
The study evaluated a total of 1,487 patient samples drawn from four independent NSCLC cohorts, making it one of the most extensive biomarker validation efforts in immuno-oncology to date. These studies included two ICI-treated cohorts—195 patients treated with anti-PD-L1 agents and 89 from the multi-center PREDAPT cohort treated with anti-PD-1 therapies—as well as two non-ICI-treated cohorts (n=193 and n=1,010, respectively). Across the ICI-treated groups, OncoPrism-NSCLC consistently predicted key clinical outcomes, including overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Crucially, OncoPrism-NSCLC showed no predictive signal in the two non-ICI cohorts, confirming that it is a predictive biomarker of ICI benefit rather than a general prognostic tool.
The findings also revealed that OncoPrism-NSCLC outperformed the current standard-of-care biomarker, PD-L1 Tumor Proportion Score (TPS), which showed no correlation with response, PFS, or OS in the PREDAPT cohort. In contrast, patients identified as “OncoPrism High” had a two to three-fold improvement in all three measures compared to lower scoring groups. These results offer oncologists a clinically actionable alternative to PD-L1 TPS, which has long struggled with limited predictive power and assay variability.
“For more than a decade, clinicians have lacked a reliable test that predicts which lung cancer patients will benefit from immunotherapy—leaving physicians and patients to make high-stakes decisions with limited information,” said Jarret Glasscock, PhD, CTO of Cofactor Genomics and senior author on the publication. “This study, drawing on nearly 1,500 NSCLC patient samples from four independent cohorts, finally delivers what the field has been asking for: a powerful immunotherapy predictive diagnostic, rather than a prognostic marker with limited clinical utility. OncoPrism-NSCLC brings precision medicine to immunotherapy.”
The test uses RNA extracted from routine formalin-fixed, paraffin-embedded (FFPE) tumor biopsy samples, making it compatible with standard clinical workflows. In addition to its analytical robustness, the test demonstrated strong reproducibility across reagent lots, operators, and processing conditions—critical attributes for robust clinical use. OncoPrism-NSCLC was initially launched last year and is run in Cofactor’s CAP-accredited, CLIA-certified laboratory. These results confirm the test’s robust predictive performance.
Key readouts from the PREDAPT NSCLC study are now available as a preprint on MedRxiv. Cofactor encourages oncologists, researchers, and healthcare partners to review the findings and learn more about how OncoPrism-NSCLC is changing the landscape of immunotherapy selection.
About Cofactor Genomics
Cofactor Genomics is a commercial stage diagnostics company that bridges the precision medicine gap by decoding RNA to solve the biggest problems in healthcare. It accomplishes this by unlocking RNA’s use as a transformational barometer of health through its PRISM database of patented Health Expression Models (HEMs). HEMs are a departure from common and often uninformative gene mutation panel tests. They represent the latest advancements in machine learning and RNA, transforming billions of biological RNA data points into Cofactor’s high-dimensional RNA models of biology, disease, and therapy response.
Cofactor’s pioneering work in RNA modeling has been published in The Journal of ImmunoTherapy of Cancer, The Journal of Molecular Diagnostics, and recognized by Nature Scientific Reports as breakthrough work in cancer. Cofactor is supported and partnered with 38 healthcare systems, representing 20% of US healthcare. Cofactor’s OncoPrism is CAP/CLIA-validated and Medicare-approved. Learn more from www.cofactorgenomics.com and LinkedIn.
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“This study, drawing on nearly 1,500 NSCLC patient samples from four independent cohorts, finally delivers what the field has been asking for: a powerful immunotherapy predictive diagnostic...OncoPrism-NSCLC brings precision medicine to immunotherapy.”