Cofactor Genomics Publishes OncoPrism-NSCLC Clinical Validation, Advancing Lung Cancer Immunotherapy Diagnostics Beyond PD-L1

The study showed OncoPrism-NSCLC significantly predicted overall response and identified the subset of patients with doubled median overall survival in response to immune checkpoint inhibitors. Additionally, the paper identified the OncoPrism biomarker across five additional cancer types

ST. LOUIS--(BUSINESS WIRE)--Cofactor Genomics today announced publication of its OncoPrism^®-NSCLC clinical validation study in npj Precision Oncology, a peer-reviewed Nature Portfolio journal. The study represents the latest results from Cofactor’s multisite PREDAPT clinical trial and extends the clinical validation of the multidimensional RNA biomarker underlying OncoPrism-HNSCC—a clinically validated, Medicare-covered test for recurrent or metastatic head and neck squamous cell carcinoma—to advance precision oncology in non-small cell lung cancer (NSCLC). This study represents a significant milestone in cancer care given NSCLC represents the largest U.S. patient population eligible for immune checkpoint inhibitor therapy.

The study demonstrated that the same biomarker underlying OncoPrism-HNSCC is represented across five additional cancer types beyond HNSCC: NSCLC, clear cell renal cell carcinoma, colon adenocarcinoma, triple-negative breast cancer, and bladder carcinoma. Building on this cross-cancer analysis, PREDAPT investigators across 17 US Health Care systems calibrated the test specifically for NSCLC and performed in-depth clinical validation against treatment response and survival outcomes. The study found high-scoring OncoPrism-NSCLC patients were significantly more likely to respond to immune checkpoint inhibitors and had significantly longer survival, with median overall survival doubled compared to the rest of the population. Importantly, the authors found that OncoPrism-NSCLC is predictive of immune checkpoint inhibitor response specifically, as it was not prognostic in patients treated with chemotherapy or other treatments.

“Precision medicine is not just about finding a target. It is about prioritizing treatment selection based on a patient’s current condition and presence of actionable biomarkers,” said Dr. Howard Bailey, Chief Medical Officer of Cofactor Genomics. "This work represents an emerging approach to immunotherapy diagnostics: integrating RNA signals from the tumor-immune microenvironment into a clinically validated prediction, rather than asking a single marker, like PD-L1 expression, to represent a complex biological response."

The publication also suggests using OncoPrism alongside PD-L1, regardless of PD-L1 score. While PD-L1 was not significantly predictive in this study, it is widely used. Among patients whose tumors already had high PD-L1 expression (TPS ≥50%), patients categorized as OncoPrism high had significantly longer progression-free and overall survival. This additional stratification supports further evaluation of complementary testing, rather than treating the two biomarkers as interchangeable. Extending clinical validation from head and neck cancer to NSCLC advances a path beyond reliance on a single protein measurement toward multidimensional RNA models that provide predictive information, particularly when PD-L1 expression alone is insufficient to guide treatment selection.

Publication

Flanagan KC, Earls J, Hiken J, et al. “Validation of a tissue-based predictive RNA test for immunotherapy benefit in NSCLC: the PREDAPT study.” npj Precision Oncology 10, 369 (2026). DOI: 10.1038/s41698-026-01632-6. https://www.nature.com/articles/s41698-026-01632-6

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. Cofactor unlocks RNA’s potential as a transformational barometer of health using patented Gene Expression Classifiers (GEC). GECs go beyond gene mutation panel tests, using the latest advancements in machine learning and RNA to create Cofactor’s high-dimensional RNA models of biology, disease, and therapy response.

Cofactor’s pioneering work in RNA-based diagnostics has been published in The Journal for ImmunoTherapy of Cancer, The Journal of Molecular Diagnostics, and recognized by Nature Scientific Reports as breakthrough work in cancer. Cofactor is partnered with doctors and healthcare systems to bring precision medicine to cancer care. Cofactor’s OncoPrism is CAP/CLIA-validated and Medicare-approved. Learn more from www.cofactorgenomics.com and LinkedIn.