FDA Breakthrough Designation Awarded to Onc.AI’s CT Scan Analysis Tool

Onc.AI has won U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its “Serial CTRS” (Serial CT Response Score) AI model, 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.

“We are honored to be awarded Breakthrough Device Designation for our Serial CTRS AI model,” Onc.AI CEO Akshay Nanduri said. “Onc.AI aims to equip oncologists with vital, automated prognostic insights using routinely collected diagnostic imaging scans and ultimately improve treatment strategy and provide risk stratification throughout a cancer patient’s journey.”

The Breakthrough Device designation underscores the potential of Onc.AI’s pipeline of 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.

A multi-institutional study demonstrated that Serial CTRS improved the prediction of overall survival for patients receiving immunotherapy compared to traditional imaging assessment tools. This highlights the model’s ability to deliver more accurate, data-driven insights into patient outcomes, enabling more precise, personalized cancer care.

“As longstanding partners of Onc.AI, we are thrilled to see the application of Flatiron’s high-quality, curated real-world data in the development and validation of regulatory-grade AI models for clinical use,” said Jacqueline Law, vice president of Corporate Strategy at Flatiron Health. “We look forward to supporting Onc.AI’s efforts collaborating with the FDA and achieving additional milestones together.”

Building on its ability to deliver insights for patient management, Serial CTRS also holds promise for transforming oncology drug development programs. Notably, it has demonstrated outperformance of the standard RECIST 1.1 in predicting overall survival.

“As part of our ongoing data and clinical collaboration with Onc.AI, we are excited to be evaluating Serial CTRS. Having been involved in product definition and evaluating results throughout the evolution of this product, I look forward to seeing this breakthrough technology enter the clinic and impact early phase trials and clinical development,” stated Dwight Owen, M.D., associate professor of Medicine and head of Thoracic Oncology at The James Cancer Center at OSU.

Onc.AI is a Canadian 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. Onc.AI is backed by premier institutional investors, including Sandbox/Blue Venture Fund, Action Potential Venture Capital, MassMutual Alternative Investments, Accomplice, Digitalis, KdT, and Life Extension Ventures. Onc.AI is also supported by the National Cancer Institute SBIR program (1R44CA291456-01A1).