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
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.
Onc.AI to Present Breakthrough Deep Learning Radiomic Biomarker Results at 2025 ASCO Annual Meeting
Onc.AI, a digital health company developing AI-powered oncology clinical management solutions, today announced that new validation study results from research collaborations with Pfizer, Baylor Scott & White and the University of Rochester Medical Center will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 30–June 3, 2025, in Chicago, IL.
Onc.AI Announces Presentation of Breakthrough-Designated AI Model Evaluated in Clinical Trial Data at AACR 2025
Onc.AI, a digital health company developing advanced AI-driven clinical management solutions for oncology, today announced that findings from a recent collaboration with global biopharma company GSK using Onc.AI’s FDA breakthrough-designated Serial CTRS AI model will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting. The study externally evaluated Serial CTRS in GSK’s GARNET Phase I clinical trial (NCT02715284) Cohort E, that enrolled patients with advanced non-small cell lung cancer (NSCLC) treated with dostarlimab, GSK’s anti-PD-1 checkpoint inhibitor.
Onc.AI Awarded FDA Breakthrough Device Designation for Serial CT Response Score Deep Learning Model
Onc.AI, a digital health company developing AI-driven oncology clinical management solutions using Deep Learning imaging AI, today announced that the U.S. Food and Drug Administration (FDA) has awarded Breakthrough Device Designation for its “Serial CTRS” (Serial CT Response Score) AI model. Serial CTRS is an artificial intelligence (AI)-based prognostic tool that uses deep learning to analyze CT scans and stratify patients into high- or low-mortality risk categories. This designation underscores the potential of Onc.AI’s pipeline of category-leading imaging AI models to provide an early and automated risk prognosis, enabling clinicians to optimize treatment decisions and surveillance of patients with metastatic non-small cell lung cancer.
Onc.AI Serial Imaging Response Score Outperforms Traditional Methods for Early Assessment of NSCLC Immunotherapy Outcomes
Onc.AI, a digital health company developing AI-driven oncology clinical management solutions, announced that results from a study evaluating the use of serial imaging in advanced non-small cell lung cancer (NSCLC) will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) annual meeting. The multi-institutional study demonstrated improved prediction of overall survival for patients receiving immunotherapy compared to traditional assessment tools.
Onc.AI Awarded $2 Million National Cancer Institute Grant to Advance AI-based Clinical Decision Support for Metastatic NSCLC
Onc.AI, a digital health company developing AI-driven oncology clinical management solutions, today announced it has been awarded a $2 million Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI). This grant will support the further development and clinical validation of Onc.AI’s advanced imaging-AI software for non-small cell lung cancer (NSCLC) clinical decision-making. The NCI’s SBIR program seeks to accelerate the translation of innovative scientific discoveries into clinical practice, emphasizing the significance of Onc.AI’s work in transforming oncology care.
Onc.AI to Present Collaboration Results Demonstrating Immunotherapy Response Prediction Using a Radiomic Signature in Late-Stage Lung Cancer
Onc.AI, a digital health company developing a novel oncology clinical management solution, today announced that new data will be presented at the 2024 Annual Society of Clinical Oncology (ASCO) resulting from its collaboration with Pfizer. The collaboration evaluated the ability of Onc.AI’s radiomics-based multimodal signature to predict immunotherapy response in metastatic lung cancer patients.
Onc.AI Raises $25 Million Series A Financing Co-Led by MassMutual and Action Potential Venture Capital
Onc.AI, a medical technology company developing a novel digital clinical management solution focused on immuno-oncology, announced today it has closed a $25 million Series A financing co-led by MassMutual and Action Potential Venture Capital (a GSK venture fund). Also participating were Life Extension Ventures and all existing investors including Blue Venture Fund, Accomplice, Digitalis Ventures, and KdT Ventures.
