Onc.AI Announces Positive External Validation of Onclara IO, a CT Imaging AI Biomarker for First-Line Immunotherapy in PD-L1-High Metastatic Non-Small Cell Lung Cancer

Onclara^TM IO, trained on Diverse Multi-Institutional Real-World Data and Externally Validated on Flatiron Health Data, Shows Significant Survival Stratification Beyond PD-L1

CHICAGO--(BUSINESS WIRE)--Onc.AI, a digital health company developing computational biomarkers and decision-support products in oncology using Deep Learning imaging AI, today announced positive external validation results for Onclara IO, an imaging-based AI biomarker that stratifies survival outcomes in patients with PD-L1-High, mutation negative metastatic non-small cell lung cancer (mNSCLC) receiving first-line immune checkpoint inhibitor (ICI) monotherapy. The findings will be presented at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting in Chicago. In an external blinded validation conducted on a Flatiron Health longitudinal imaging dataset, Onclara IO derived from a single pretreatment CT scan, the patients most likely to benefit from ICI monotherapy.

In the retrospective validation cohort of 205 patients with PD-L1-High mNSCLC without actionable mutations, patients classified as Onclara IO High had a median overall survival of 484 days, compared to 155 days for Onclara IO Low patients. “These results position Onclara IO as a noninvasive imaging biomarker that complements PD-L1 testing, with the potential to inform first-line treatment selection and risk-adapted strategies in this population,” said Ravi Parikh, MD, first author on this work and Medical Director of the Winship Data and Technology Applications Shared Resource at Winship Cancer Institute, Emory University.

"As longstanding partners of Onc.AI, we are pleased to see Flatiron's high-quality, real-world data support the independent validation of Onclara IO in patients with PD-L1-high metastatic non-small cell lung cancer. These findings reinforce the value of combining curated real-world data with imaging AI to advance more precise, biomarker-informed treatment decisions, and we look forward to continuing this collaboration as Onc.AI achieves additional milestones together," said Jacqueline Law, Ph.D., VP, Scientific Engagement and Applied Research at Flatiron Health.

Onclara IO is not FDA cleared and is not available for commercial use. Onc.AI expects to submit Onclara IO for clearance as a software-as-medical-device in 2027.

About Onc.AI

Onc.AI is a digital health company developing AI-driven oncology clinical management solutions using advanced Deep Learning applied to routine diagnostic images. The company’s platform is applied at the point of care to medical oncologists and is also leveraged by global pharmaceutical leaders to accelerate oncology drug development. Onc.AI is backed by premier institutional and corporate investors, including: Sandbox/Blue Venture Fund, GSK plc, Accomplice, MassMutual Alternative Investments, Digitalis, KdT, and Life Extension Ventures. Onc.AI is also supported by the National Cancer Institute SBIR program (1R44CA291456-01A1).