What TOBY does

TOBY, Inc. is a pre-commercial biotechnology company developing a urine-based diagnostic platform that uses volatolomics — the analysis of volatile organic compounds (VOCs) in urine — combined with mass spectrometry and proprietary AI/ML algorithms to detect early-stage disease, beginning with cancer. The company has assembled three indication-specific tests: a bladder cancer detection test (FDA Breakthrough Device Designation, June 2025), a Multi-Cancer Early Detection (MCED) test designed to identify more than ten cancers from a single urine sample and covering over 60% of global cancer cases (Breakthrough Designation, April 2026 — the first ever awarded to a urine-based MCED technology), and an Alzheimer's disease diagnostic test (Breakthrough Designation, May 2026). The underlying TOBY™ Platform / Volatomic Insights architecture ingests a urine sample, runs mass spectrometry to read molecular signatures, and applies machine learning to determine whether the sample is disease-positive or negative.

The business model is diagnostic testing services targeting healthcare providers, health systems, and adults aged 50+, with planned distribution through hospitals and clinical laboratories once FDA approval and reimbursement are secured. TOBY has not yet launched a commercial product, has no publicly disclosed pricing, and is generating no revenue. The company was founded in 2023 by Matthew Laskowski (CEO) and Dragan Sebišanović (CSO), is headquartered in Austin, Texas with operations in Boston, and has 1-10 employees. Capital structure consists of a ~$1.4M disclosed equity round (February 2025) plus non-dilutive support from the Massachusetts AI Health Innovation Grant, the Mayo Clinic & ASU MedTech Accelerator (2025 cohort), Nashville Entrepreneur Center's Project Healthcare (HCA Healthcare Scholar), LifeX, and MassChallenge. The board and advisory bench includes diagnostic and healthcare operators such as Dan Collins (founder of GenesisCare) and Matthew Collier (ex-McKinsey/Bain/Accenture diagnostics CEO), with clinical evidence generation led by a Duke University prostate cancer study.

Name

TOBY

Legal name

TOBY, Inc.

Website

https://toby.health

Company type

Private

Founded year

2023

Operating status

Operating

Headcount range

1–10 employees

Short description

TOBY is a pre-commercial biotechnology company developing AI-powered, urine-based diagnostic tests for early cancer and Alzheimer's detection, using mass spectrometry and proprietary machine learning to analyze volatile organic compound signatures for healthcare systems and at-risk adults.

Ownership category

akta.pro rank

Product category

Cancer Diagnostics

NAICS

Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industry

Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)

Keywords

• Urine-based diagnostics
• Cancer screening
• Mass spectrometry analysis
• AI medical diagnostics
• Volatolomics platform

Headquarters

HQ city

New City

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations

Revenue model

1. Diagnostic Testing Services: TOBY generates revenue through urine-based diagnostic tests that detect cancer and other diseases. The test requires only a single urine sample, offering an alternative to blood-based screening approaches. The company is working toward FDA approval and reimbursement to enable commercial launch.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

TOBY develops a urine-based diagnostic platform that combines mass spectrometry with proprietary artificial intelligence to analyze volatile organic compounds (VOCs) in urine for early detection of cancer and other diseases. The company's three FDA Breakthrough Device designated products — Multi-Cancer Early Detection (MCED), bladder cancer detection, and Alzheimer's disease diagnosis — analyze urinary molecular signatures from a single non-invasive sample to identify disease patterns often before symptoms appear. The platform is positioned as a low-cost, scalable, non-invasive alternative to blood-based or imaging-based screening.

Product overview

TOBY is a biotechnology company offering a unified urine-based diagnostic platform (TOBY™ Platform/Volatomic Insights) using volatolomics, mass spectrometry, and AI. The platform comprises three core products: the Multi-Cancer Early Detection (MCED) Test designed to detect multiple cancers from a single urine sample, the TOBY Test for Bladder Cancer using gas chromatography-mass spectrometry and AI for cancer risk scoring, and the TOBY Alzheimer's Test using urinary VOC patterns for cognitive evaluation. All products analyze volatile organic compounds (VOCs) in urine through mass spectrometry, with proprietary AI interpreting molecular signatures to detect disease patterns. The platform represents over 60% of global cancer cases detection capability.

Differentiator

Problem solved

Functional benefit

Products and services

• TOBY Alzheimer's Test Urine-based diagnostic test that analyzes urinary volatile organic compound (VOC) patterns through mass spectroscopy and machine learning algorithms to aid in diagnosis of Alzheimer's disease in adults aged 50 and older presenting with signs and symptoms of cognitive impairment.
• TOBY Multi-Cancer Early Detection (MCED) Test Urine-based multi-cancer early detection test that analyzes volatile organic compounds (VOCs) in urine using mass spectrometry and machine learning to identify cancer-associated molecular patterns from a single non-invasive sample, covering more than ten cancers representing over 60% of global cancer cases.
• TOBY Test for Bladder Cancer AI-powered urine test for early bladder cancer detection that uses gas chromatography-mass spectrometry and proprietary AI to generate real-time cancer risk scores from volatile organic compounds in a single urine sample.
• TOBY™ Platform Volatolomics platform that mimics the disease-sensing power of dogs using urine signatures and AI for fast, non-invasive screening and diagnostics, combining advanced mass spectrometry, machine learning, and privacy-first architecture.

Quantifiable outcome

• Detects over 10 cancers from a single urine sample
• +2 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature4 records

Partnerships

Seven partnerships are on record, tiered flagship, core and minor.

• Mayo Clinic & ASU Alliance for Health Care MedTech AcceleratorflagshipStrategic or Co-development Partner · 23 June 2025Flagship program of Mayo Clinic and Arizona State University Alliance for Health Care supporting early-stage health tech companies with expert mentoring, personalized strategy, and clinical validation opportunities. TOBY completed participation in the 2025 cohort (selected from global pool of applicants).
• Nashville Entrepreneur Center - Project HealthcarecoreStrategic or Co-development Partner · 23 June 2025Healthcare accelerator backed by Nashville Entrepreneur Center helping healthcare startups scale by connecting them with customers, capital, and industry experts. TOBY completed this four-month program as an HCA Healthcare Scholar, gaining strategic mentorship and industry connections.
• LifeX Life Sciences AcceleratorminorStrategic or Co-development PartnerSupports early-stage healthcare companies preparing to bring science-driven technologies to market, with focus on clinical and operational readiness. TOBY participated in this pre-commercialization accelerator.
• MassChallengeminorStrategic or Co-development PartnerGlobally competitive, equity-free accelerator for high-impact ventures. TOBY was selected from over 1,300 startups for early-stage support.
• Duke UniversitycoreStrategic or Co-development PartnerDuke-led prostate cancer study using TOBY's urine volatilomic technology. Preliminary findings were selected for podium presentation at the American Urological Association Annual Meeting and oral presentation at the Focal Therapy Society 2026 meeting. Study explores AI-driven detection of low-PSA prostate cancer and MRI-invisible lesions.
• Cambridge Innovation Center (CIC)minorImplementation/ SI/ Consulting PartnerCIC assisted TOBY in software development efforts as part of the Massachusetts AI Health Innovation Grant.
• McDermott Will & EmeryminorImplementation/ SI/ Consulting PartnerTOBY was selected for McDermott Will & Emery's competitive LEAP Program, gaining elite legal and strategic support for growth in cancer detection.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Freenome: Freenome is a privately-held multi-cancer early detection company using a blood-based multiomics platform (cell-free DNA, methylation, proteins) combined with AI. It is a direct competitor in the MCED space pursuing similar clinical validation and FDA breakthrough pathways.
• C2N Diagnostics: C2N Diagnostics pioneered the PrecivityAD blood-based biomarker test for Alzheimer's disease detection. It directly parallels TOBY's FDA Breakthrough-designated Alzheimer's diagnostic test, addressing the same patient population (adults 50+ with cognitive impairment) with a different analyte matrix (blood vs. urine).
• GRAIL: GRAIL's Galleri is the leading blood-based multi-cancer early detection (MCED) test, making it the most direct comparable to TOBY's urine-based MCED test in terms of clinical use case (early detection of multiple cancers from a single non-invasive sample) and regulatory positioning (Breakthrough Device Designation + CMS coverage pathway).
• Owlstone Medical: Owlstone Medical is the leading volatolomics / breath-based diagnostics company using VOC biomarkers and proprietary chemical sensors for early disease detection including cancer. It is the most scientifically analogous peer to TOBY's urine-VOC platform, sharing the core volatolomics method architecture.

Broad incumbents

• Guardant Health: Guardant Health is an established leader in liquid biopsy oncology diagnostics (Guardant360 CDx, Shield for CRC screening). As a publicly-traded incumbent with deep clinical evidence, regulatory infrastructure, and payer relationships in oncology diagnostics, it is a relevant broad-incumbent peer even though it does not compete in volatolomics or urine-based detection.
• Exact Sciences: Exact Sciences is a publicly-traded leader in cancer screening (Cologuard for CRC, Oncotype DX, and now Thrive Earlier Detection MCED after acquisition). It represents the dominant commercial-scale reference point for non-invasive cancer screening commercialization, GTM, and reimbursement.

Emerging players

• Universal Diagnostics: Universal Diagnostics is developing a blood-based multi-cancer screening test using metabolomics and machine learning, targeting colorectal and other cancers. It is an emerging-stage peer with thematic overlap in early-detection cancer diagnostics using advanced chemistry and AI.
• VolitionRx: VolitionRx is developing blood-based Nu.Q nucleosome-based biomarker tests for cancer detection and other diseases. It is an emerging-stage peer pursuing diagnostic tests using biomarker-based approaches, although focused on a different molecular analyte than volatolomics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds1 record

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about TOBY