Internal study
Multi-cancer retrospective analysis
Internal retrospective analyses using stored urine samples are helping us understand how the platform distinguishes cancer from non-cancer and identifies likely cancer types at early stages.
Turn a simple urine sample into early-stage cancer insight
Toby Oncology’s AI-powered, urine-based platform is built to detect cancers at stages 1 and 2 using lab workflows that already exist.
A urine-based, multi-cancer platform
Urine chemistry + AI for early detection
Toby Oncology’s platform combines urine chemistry and machine learning to look for cancer signals earlier in the disease course. It’s designed to be:
Urine-based
Uses a standard urine sample collected at home or in-clinic, no needles or imaging.
Multi-cancer
Reads signals from the 10 most common cancers in a single, unified platform.
Lab-ready
Uses standard handling, storage, and lab equipment, fitting into existing workflows and supports cost-effective testing at scale.
How it works
From sample to signal
The test turns a standard urine sample into a chemical fingerprint, then uses AI to decide whethera cancer signal is present and where it may be coming from.
Collect
A patient provides a urine sample—at home, in the clinic, or via mobile collection—using a simple kit and instructions.
Measure
A lab processes the sample using established methods similar to high-volume urine testing and measures thousands of volatile organic compounds (VOCs) and related features.
Analyze & report
AI models analyze the pattern of signals to determine whether a cancer signal is likely present and to rank likely cancer types. The goal is to return a clear, clinician-friendly result that can fit into existing workflows.
Performance & validation
Early research and ongoing validation
Our validation program includes internal retrospective analyses, external blinded studies, and a growing body of published research on urine-based VOCs for cancer detection. These efforts are focused on understanding how the platform performs at early stages across multiple cancer types.
Model research
Sensitivity and specificity evaluation
Internal research studies evaluate sensitivity, specificity, and separation between cancer and non-cancer classifications to inform ongoing model development.
Independent literature
3rd party published VOC studies
Independent peer-reviewed studies have reported performance for VOC-based cancer detection across a range of tumor types, providing important context for the platform’s approach.
Regulatory milestone
FDA Breakthrough Device designation
Our multi-cancer early detection (MCED) test for the 10 most common cancers has received FDA Breakthrough Device Designation.
*These activities are conducted for research and development purposes and are not CLIA-validated clinical performance claims. The Toby Oncology test is currently used in clinical research and trials and is not yet broadly available for routine clinical use or population-wide screening. Performance metrics may change as additional data become available.
ENCOURAGING PERFORMANCE
A review of 63 VOC cancer studies found pooled sensitivity of 79% and specificity of 89% for detecting cancer.
— JAMA Network
For clinicians
Clinical workflow
Tests are ordered for appropriate patients. Urine is collected at home with a simple kit or during a doctor visit, then sent to a Toby-enabled lab for analysis and a clear result.
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1
ORDER
Test ordered for appropriate adults based on clinical judgment and guidelines.
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2
COLLECT
Urine sample collected at home using a Toby kit or during a routine visit.
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3
RUN
Sample processed and analyzed in a lab running the Toby Oncology assay.
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4
REVIEW
Result returned to the clinician to inform follow-up and further evaluation.
For labs and life sciences
Lab, trial, and monitoring applications
The Toby Oncology platform generates multi-cancer signal data that labs and life sciences teams can use in real-world workflows, clinical studies, and exploratory trials.
Labs and diagnostic networks
Reference labs and diagnostic networks can run the assay on standard equipment and existing sample-handling workflows, making it practical to scale testing volume as programs grow and to support repeat testing.
Trials and research
Life sciences and pharma teams use urine-based multi-cancer signals to help enrich high-risk cohorts, explore how signals relate to treatment response, and add a non-invasive readout alongside existing biomarkers and imaging.
Longitudinal monitoring
Current and planned studies are assessing how repeated urine samples can support longitudinal monitoring in high-risk patients and survivors, tracking changes in signals over time to inform follow-up.
For inquiries about lab deployments, clinical trials, or partnerships, please contact our team.
Under the hood
Technology and IP
Behind the test is a combination of chemistry, machine learning, and IP designed to be durable over time.
Signal and models
The platform reads thousands of VOC and related features per sample and uses machine learning to distinguish cancer from non-cancer and to localize likely cancer types.
Indications
Current studies span 10 major cancers, including both cancers with established screening programs and those with limited or no routine screening today.
IP MOAT
Patent filings cover key elements of sample processing, model design, biomarker combinations, and clinical indications, with the goal of protecting the performance “core” of the platform as it scales.
Next Steps
If you believe early detection should truly be early, we’d love to hear from you
For partnership or investment inquiries, please include your organization and area of interest.