Onc.AI Awarded FDA Breakthrough Device Designation for Serial CT Response Score Deep Learning Model

Breakthrough Serial CTRS Model Also Has Potential to Transform Oncology Drug Development

SAN CARLOS, Calif. & WATERLOO, Ontario--(BUSINESS WIRE)--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.

Recently, Onc.AI presented results at the Society for Immunotherapy of Cancer (SITC), showcasing a multi-institutional study demonstrating 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.

“We are honored to be awarded Breakthrough Device Designation for our Serial CTRS AI model,” said Akshay Nanduri, CEO of Onc.AI. “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.”

“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, VP 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 robust 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, paving the way for superior decision-making in trial design and clinical development decisions for novel oncology therapeutics.

“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,” said Dwight Owen, MD, MS, Associate Professor of Medicine and Head of Thoracic Oncology at The James Cancer Center at OSU.

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 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).