How Onclara™ Works

Go beyond simple and coarse tumor measurement

Image Ingest

  • Onclara™ can be deployed directly in pharma cloud environment (i.e, Microsoft Azure Foundry) for ingest
  • CT scans can also be securely uploaded to Onclara™ Studio (cloud-hosted)
  • Data transfer also supported by leading pharma/oncology CROs
  • Handles baseline-only and all scans
  • Secure, fully de-identified data pipeline with automatic quality control and self-correction

Predict and Analyze

  • CT scan from all major hardware vendors are seamless harmonized and scans covering chest/abdomen/pelvic regions are stitched together
  • Achieve superior survival prediction compared to RECIST with Onclara™ Evaluate
  • Drivers of patient risk also determined (tumor burden, body composition, vasculature).
  • Generates structured, standardized scores at both individual patient and cohort levels

Apply

  • Enables more confident go/no-go decisionmaking in Phase IB and Phase II solid tumor trials
  • Onclara™ AI models can also be used for effective comparison of treatment arms, prospective enrichment and patient stratification

Onclara™ Studio

Cloud-based intuitive visual and tabular outputs for immediate review or biostatistical analysis

Cohort-level analysis and Kaplan Meier curve

Patient-level analysis, tumor burden

Patient-level analysis, body composition

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Benefits

Fully Automated, End-to-End Deep Learning Pipeline

Effortless Integration: Seamlessly fits into existing clinical workflows.
No Annotations Required: Eliminates manual annotation, saving significant time and cost.
Completely Automated: Provides consistent, objective biomarker assessments.

Smarter Clinical Trial Design

  • Enhance trial precision and efficiency with AI-driven patient stratification.
  • Utilize advanced deep learning biomarkers to balance treatment arms.
  • Apply sophisticated risk scores and propensity score matching to optimize patient selection.

Accelerate Early-Phase Decisions

  • Quickly gain data-driven insights into therapeutic efficacy.
  • Inform critical go/no-go decisions early in the clinical process.
  • Efficiently compare treatment responses across various dose levels.

Improve Phase 3 Success Rates

  • Refine patient selection and tailor endpoint strategies.
  • Leverage robust deep learning radiomic biomarkers for quantitative outcome predictions.
  • Enhance confidence in pivotal clinical trial decisions.

How it Works

Leverage patient-specific prognostic risk assessments powered by advanced deep-learning AI biomarkers to refine clinical decisions for patients

Order the Test

  • Oncologist initiates an order for Onclara
  • Evaluate or Onclara
  • IO
  • Routine clinical CT scans are securely retrieved and processed with no additional input or manual annotation required
  • Predictions are returned to the ordering oncologist (PDF report or directly on oncology EMR)

AI-Driven Analysis

Sophisticated deep-learning AI models automatically extract clinically relevant imaging biomarkers:

  • Tumor radiomic signature (intensity, texture, morphology)
  • Multi-site tumor burden (volume and spatial distribution across affected organs)
  • Vascular structure and morphology
  • Advanced body composition metrics

Actionable Reporting

Within 24 hours, oncologists receive a comprehensive and intuitive report featuring:

  • Onclara™ IO: High/low risk stratification for 12-month overall survival in PDL1-High mutation negative mNSCLC (just using a patient’s baseline/pre-treatment CT scan)
  • Onclara™ Evaluate: Identification of the highest risk patients and presentation of a calibrated probability of the patient achieving 12 month overall survival (for mutation negative mNSCLC, PDL1-High/Low/Neg)

Facilitates informed clinical decision-making, enabling personalized treatment strategies tailored to individual patient risk.

Highlights

Clinical Solutions – Transforming Imaging into Powerful Insights

Onc.AI reveals critical insights beyond what the human eye can detect, turning routine imaging into powerful insights to inform clinical decisions.

Onclara™ Evaluate

January 2025

Granted FDA Breakthrough Device Designation. Actively engaged in accelerated review and sprint process with FDA.

Onclara™ IO

Expecting to submit to FDA in 2027

Rigorously externally validated using a large real-world dataset from Flatiron Health

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