Onc.ai

San Carlos, CA, United States (with an additional office in Waterloo, ON, Canada)  All United States companies → Founded 2020
Biotech / Drug Discovery Imaging AI Specialist Specialty-Focused AI
Series A — $31M - $37M

Products

Onclara™ (by Onc.ai)
Onc.ai
Clinical Decision Support & Reference
Onc.ai develops AI-powered technology, including the Onclara™ platform, to improve oncology decision-making in clinical trials and practice by leveraging real-world oncology data for predictive and prognostic models.

See all 1 product →

About Onc.ai

Onc.ai is a privately held digital health company dedicated to improving oncology decision-making through advanced AI-powered imaging biomarkers. Their Onclara™ platform utilizes a comprehensive real-world oncology dataset, including diagnostic imaging, EMRs, and genomics, to train predictive and prognostic AI models. These models are designed to extract and quantify complex imaging features from routine CT scans—such as tumor radiomic signatures, multi-site tumor burden, vascular structure, and body composition—that are often imperceptible to the human eye.

For physicians, Onc.ai’s solutions aim to provide clearer insights into disease progression and therapeutic effectiveness, thereby supporting personalized treatment decisions. Their products, such as Onclara™ Evaluate and Onclara™ IO, are developed to assist in areas like Phase IB/Phase II clinical trial decision-making for pharmaceutical companies and predicting response and outcomes for metastatic lung cancer patients treated with immunotherapy. The company’s Serial CT Response Score (Serial CTRS) AI model has received FDA Breakthrough Device Designation, and their Lung Clinical Management (LCM) product is currently under FDA review, highlighting their commitment to bringing validated AI tools into clinical practice.

Focus Areas

AI in oncology precision oncology deep learning imaging radiomics clinical decision support pharmaceutical clinical development metastatic lung cancer immunotherapy response prediction

Business Intelligence

Key InvestorsNational Cancer Institute, 515 Ventures, Action Potential Venture Capital, Life Extension Ventures, Massachusetts Mutual Life Insurance, Blue Venture Fund, Accomplice, Digitalis Ventures, KdT Ventures
PartnershipsFlatiron Health, GSK, Pfizer, Oracle Cloud Infrastructure (OCI), Valohai
TechnologyCloud-based analytics interface, deep learning imaging platform, multimodal modeling approach, leverages Valohai MLOps platform on Oracle Cloud Infrastructure (OCI) for GPU workloads across AWS, Azure, and GCP.
FDA Clearances1 (FDA Breakthrough Device Designation for Serial CTRS AI model) cleared products (estimated)

What Physicians Need to Know

Specialization: AI in Oncology & Precision Oncology
Onc.AI leverages deep learning imaging AI to radically improve oncology decision-making, focusing on precision oncology. They develop AI models that analyze CT scans to enhance cancer treatment decisions and optimize pharmaceutical clinical trials.
Specialization: Deep Learning Imaging & Radiomics
The company specializes in deep learning imaging AI, extracting clinically relevant imaging biomarkers such as tumor radiomic signatures (intensity, texture, morphology), multi-site tumor burden, vascular structure, and advanced body composition metrics from routine CT scans.
Specialization: Clinical Decision Support
Onc.AI provides imaging-based clinical decision support services, particularly for metastatic lung cancer, by producing patient-specific prognostic scores and clinician-facing reports to inform treatment decisions.
Specialization: Pharmaceutical Clinical Development
They offer solutions to accelerate early-phase clinical trial decisions, improve Phase 3 success rates, and enhance trial precision and efficiency with AI-driven patient stratification and advanced deep learning biomarkers.
Specialization: Metastatic Lung Cancer & Immunotherapy Response Prediction
Onc.AI has products like Onclarau2122 IO, which predicts response and outcomes for metastatic lung cancer patients treated with immunotherapy. Their Serial CT Response Score (CTRS) deep learning model is FDA-breakthrough designated for evaluating changes across routine CT scans to predict overall survival in late-stage non-small cell lung cancer (NSCLC) and other solid tumor types.
Key Differentiator: Market-Leading Real-World Dataset
Onc.AI's Onclarau2122 platform is trained on a market-leading oncology real-world dataset to develop best-in-class predictive and prognostic AI models.
Key Differentiator: FDA Breakthrough Device Designation
Their Serial CT Response Score (CTRS) deep learning model has received FDA Breakthrough Device Designation, highlighting its potential for accelerated regulatory review and superior prediction of overall survival compared to conventional imaging.
Key Differentiator: Fully Automated, End-to-End Deep Learning Pipeline
Their technology offers a fully automated, end-to-end deep learning pipeline that seamlessly integrates into existing clinical workflows, requires no manual annotations, and provides consistent, objective biomarker assessments.
Technology Stack: Deep Learning & Radiomics
Onc.AI utilizes sophisticated deep learning AI models to automatically extract clinically relevant imaging biomarkers and employs radiomic feature extraction and CT image volumetric analysis.
Technology Stack: Cloud-Based Solutions
Their models are deployed through a cloud-hosted solution, such as Onclarau2122 Studio, and can be integrated into pharma cloud environments like Microsoft Azure Foundry, with data transfer supported by leading pharma/oncology CROs.
Technology Stack: MLOps Platform
Onc.AI leverages the Valohai MLOps platform, running on powerful GPUs (e.g., Oracle Cloud's A10 GPUs), to accelerate biomarker development, manage infrastructure resources across multiple cloud providers, and ensure traceability and reproducibility of models.
Physician Tip

For physicians, Onc.AI's solutions offer enhanced clarity in oncology decision-making by providing patient-specific prognostic risk assessments and standardized imaging biomarker reports. The Onclarau2122 IO product can help predict response and outcomes for metastatic lung cancer patients undergoing immunotherapy, aiding in personalized treatment strategies. The automated nature of their deep learning pipeline means routine CT scans can be processed without additional input, delivering predictions directly to the oncology EMR or as PDF reports. This allows for more informed discussions with patients about care goals and potential treatment changes, especially for identifying poor prognosis patients who may benefit from altered strategies or increased surveillance.

Onc.AI's platform is designed for effortless integration into existing clinical workflows. It can securely retrieve and process routine clinical CT scans and return predictions as PDF reports or directly into oncology EMR systems. For pharmaceutical partners, Onclarau2122 can be deployed directly in their cloud environments (e.g., Microsoft Azure Foundry) or data can be securely uploaded to Onclarau2122 Studio, with data transfer also supported by leading pharma/oncology CROs.

Products by Onc.ai

1 product in the directory

Onclara™ (by Onc.ai)
Onc.ai
Clinical Decision Support & Reference
Onc.ai develops AI-powered technology, including the Onclara™ platform, to improve oncology decision-making in clinical trials and practice by leveraging real-world oncology data for predictive and prognostic models.

What the Web Says

Onc.ai is a digital health company focused on improving oncology decision-making through AI-powered predictive and prognostic models. Their Onclarau2122 platform leverages real-world oncology data to enhance clinical trial decision-making and predict treatment response for metastatic lung cancer. The company has received FDA Breakthrough Device Designation for one of its products.

Overall: Positive

Strengths

  • Developing innovative AI imaging models for precision oncology.
  • Opportunity to make a meaningful impact on cancer treatment.
  • Talented, curious, and collaborative team.
  • Remote-first company with company-sponsored events.
  • Unlimited PTO and solid healthcare benefits (US and Canada).
  • Opportunities for continuous learning and professional growth.

Limitations

  • Limited public product reviews available on major platforms like G2, Glassdoor, and Capterra.
  • Some general skepticism on Reddit regarding the current capabilities of AI in oncology for critical decision-making, with concerns about data interpretation, hallucinations, and ethical considerations.
  • The broader field of AI in oncology faces challenges in critical data appraisal and the need for human interaction.

Based on reviews from: Onc.ai Website, Reddit, Capterra, G2

Last updated: 2026-06-19

Videos

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Press & Coverage

Onc.ai
Onclarau2122 IO validated on comprehensive metastatic real-world dataset from Flatiron Health, ASCO 2026
Onc.AI announced the validation of its Onclarau2122 IO product on a comprehensive metastatic real-world dataset from Flatiron Health, with findings to be presented at ASCO 2026. This AI-powered tool predicts response and outcomes for metastatic lung cancer patients treated with immunotherapy.
2026-06
Business Wire
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 announced positive external validation results for Onclara IO, an imaging-based AI biomarker for stratifying survival outcomes in mNSCLC patients receiving first-line immune checkpoint inhibitor monotherapy. These findings will be presented at the ASCO 2026 Annual Meeting.
2026-05
Business Wire
Onc.AI Announces Presentation of Breakthrough-Designated AI Model Evaluated in Clinical Trial Data at AACR 2025
Onc.AI announced that findings from a collaboration with GSK, evaluating Onc.AI's FDA breakthrough-designated Serial CTRS AI model, will be presented at the 2025 AACR Annual Meeting. The study externally evaluated Serial CTRS in GSK's GARNET Phase I clinical trial.
2025-04
AuntMinnie
Onc.AI gets FDA nod for Serial CT Response Score AI model
Onc.AI received FDA Breakthrough Device Designation for its Serial CT Response Score (Serial CTRS) AI model, an AI-based prognostic tool for metastatic non-small cell lung cancer. This designation aims to accelerate regulatory review for the device.
2025-02
Flatiron Health
Onc.AI Awarded FDA Breakthrough Device Designation for Serial CT Response Score Deep Learning Model
Onc.AI was awarded FDA Breakthrough Device Designation for its Serial CT Response Score (Serial CTRS) AI model, an AI-based prognostic tool that uses deep learning to analyze CT scans and stratify patients into high- or low-mortality risk categories.
2025-02
Onc.ai
$2mm National Cancer Institute SBIR Grant
Onc.AI was awarded a $2 million SBIR grant from the National Cancer Institute to advance AI-based clinical decision support for metastatic NSCLC.
2024-11
Startup Intros
Onc.AI - Series A Funding
Onc.AI raised $25 million in Series A financing in January 2023, co-led by MassMutual and Action Potential Venture Capital.
2023-01
Startup Intros
Onc.AI - Seed Funding
Onc.AI raised $6 million in Seed financing in December 2020, co-led by Blue Venture Fund and Accomplice.
2020-12

Frequently Asked Questions

Onc.ai offers the Onclarau2122 platform, which includes Onclarau2122 IO and Onclarau2122 Evaluate. Onclarau2122 IO provides high/low risk stratification for 12-month overall survival in PDL1-High mutation-negative metastatic non-small cell lung cancer (mNSCLC) using baseline CT scans. Onclarau2122 Evaluate identifies high-risk patients and presents a calibrated probability of achieving 12-month overall survival for mutation-negative mNSCLC (PDL1-High/Low/Negative). These tools are designed to inform clinical decisions and are currently investigational.
Onc.ai's Serial CT Response Score Deep Learning Model has been granted FDA Breakthrough Device Designation, indicating it is undergoing an accelerated review process. While their current products, Onclarau2122 IO and Onclarau2122 Evaluate, are investigational and not yet FDA cleared for clinical use, Onc.ai emphasizes a secure, fully de-identified data pipeline with automatic quality control. The company also works to ensure clinical-ready compliance by leveraging platforms like Oracle Cloud Infrastructure. The broader regulatory landscape for AI in healthcare, including the ONC's HTI-1 final rule, requires transparency and risk management for predictive decision support interventions, which Onc.ai's solutions would need to align with as they move towards clinical deployment.
While specific pricing details are not publicly disclosed, the cost of implementing AI in healthcare can vary significantly. For advanced diagnostic and imaging AI systems, costs typically range from $200,000 to $1,000,000, depending on complexity and customization, including specialized hardware, software integration, and regulatory approval. Mid-level AI systems for broader functionality and clinical decision support can range from $100,000 to $500,000. Enterprise-level AI platforms can exceed $1 million. Pricing models in health tech often revolve around value-based metrics, such as improved revenue capture or reduced denial rates.
Onc.ai offers production support through a dedicated email address ([email protected]) and general inquiries can be directed to [email protected]. Their platform is designed for effortless integration into existing clinical workflows and is fully automated, eliminating the need for manual annotation. This suggests a focus on user-friendly design to minimize the need for extensive technical assistance. Onc.ai also provides comprehensive and intuitive reports to oncologists within 24 hours.
Onc.ai partners with leading pharmaceutical companies and research institutions to validate and advance its AI models. They have ongoing collaborations with Pfizer, Baylor Scott & White, and the University of Rochester Medical Center for validation studies. These partnerships are crucial for enhancing trial precision and efficiency, accelerating early-phase decisions in pharmaceutical clinical development, and improving Phase 3 success rates through AI-driven patient stratification and advanced deep learning biomarkers. Onc.ai also leverages a market-leading oncology real-world dataset to train its AI models.
Onc.ai is a privately held digital health company founded in 2020. They have raised a total of $37.0 million across three funding rounds, including a $25.0 million Series A in January 2023. Their investors include Blue Venture Fund, Accomplice, MassMutual, and Action Potential Venture Capital. This funding indicates significant investor confidence and a solid financial foundation for continued development and operations.
Onc.ai utilizes sophisticated deep-learning AI models to automatically extract clinically relevant imaging biomarkers from routine CT scans, including tumor radiomic signatures (intensity, texture, morphology), multi-site tumor burden, and vascular structure. These advanced radiomics and machine learning techniques identify biomarkers that predict responses to PD-(L)1 inhibitors without invasive biopsies. For metastatic lung cancer, their Onclarau2122 IO model specifically predicts high/low risk stratification for 12-month overall survival in PDL1-High mutation-negative mNSCLC using baseline CT scans. This approach has shown superior survival prediction compared to traditional methods like RECIST.

Investors

Who's funded Onc.ai.

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