Cofactor Genomics Validates RNA-Based Biomarker for NSCLC Immunotherapy Response in 1,400+ Patient Study
Key Insights
Cofactor Genomics (search)' PREDAPT trial validated the OncoPrism-NSCLC (search) test across 1,487 patient samples from four independent cohorts, representing one of the most extensive biomarker validation efforts in immuno-oncology.
The RNA-based diagnostic outperformed the current standard PD-L1 (search) Tumor Proportion Score, showing patients identified as "OncoPrism High" had two to three-fold improvement in response rates, progression-free survival, and overall survival.
Strategic investments from Labcorp and Ascension Ventures (search) will accelerate nationwide expansion of the immunotherapy-response diagnostic across U.S. cancer care networks.
Cofactor Genomics (search) has announced breakthrough results from its PREDAPT non-small cell lung cancer (NSCLC) trial, validating the company's OncoPrism-NSCLC (search) test as a superior predictive biomarker for immune checkpoint inhibitor (ICI) therapy response. The comprehensive study evaluated 1,487 patient samples across four independent NSCLC cohorts, establishing one of the most extensive biomarker validation efforts in immuno-oncology to date.
Superior Performance Over Current Standard
The RNA-based diagnostic demonstrated significant advantages over the current standard-of-care biomarker, PD-L1 (search) Tumor Proportion Score (TPS). While PD-L1 TPS showed no correlation with response, progression-free survival (PFS), or overall survival (OS) in the PREDAPT cohort, patients identified as "OncoPrism High" achieved two to three-fold improvement in all three clinical measures compared to lower scoring groups.
The study design included two ICI-treated cohorts—195 patients treated with anti-PD-L1 (search) agents and 89 from the multi-center PREDAPT cohort treated with anti-PD-1 (search) therapies—alongside two non-ICI-treated cohorts (n=193 and n=1,010, respectively). Across the ICI-treated groups, OncoPrism-NSCLC (search) consistently predicted key clinical outcomes, including overall response rate (ORR), progression-free survival, and overall survival.
Predictive Specificity Confirmed
Crucially, the diagnostic showed no predictive signal in the two non-ICI cohorts, confirming its role as a predictive biomarker of ICI benefit rather than a general prognostic tool. This specificity addresses a critical need in oncology, where distinguishing between predictive and prognostic biomarkers is essential for treatment decision-making.
Strategic Investment Fuels Expansion
Cofactor Genomics (search) has secured strategic investments from Labcorp and Ascension Ventures (search) to accelerate nationwide expansion of its OncoPrism platform. Ascension Ventures, the strategic investment arm of 13 leading U.S. health systems across 22 states representing more than $100 billion in annual operating revenue, aligns with some of the nation's largest oncology networks.
"This is a major step in ensuring that every patient—regardless of treatment location—has access to a predictive diagnostic that can guide the use of immunotherapy," said Chris Parker, CEO of Cofactor Genomics (search). "Labcorp's nationwide diagnostic network, combined with Ascension Ventures (search)' reach across major U.S. health systems, provides a strong foundation as we scale access to OncoPrism and continue expanding into new cancer indications."
Technology Platform and Clinical Impact
OncoPrism leverages machine-learning analysis of tumor RNA to quantify immune engagement and generate clinically actionable predictive classifications for immune checkpoint inhibitor response. The platform's capabilities were established in the national PREDAPT trial, demonstrating multi-cancer applicability and performance exceeding existing clinically validated and Medicare-covered diagnostics.
The diagnostic moves beyond the constrained utility of prognostic biomarkers, delivering predictive insight directly linked to ICI treatment outcomes. This positions OncoPrism as one of the few diagnostics capable of guiding immunotherapy use in both academic and community oncology settings, where advanced molecular tools have traditionally been difficult to adopt.