AUSTIN, Texas, May 26, 2026
TOBY, Inc., a biotechnology company focused on non-invasive disease detection technologies, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s investigational TOBY Alzheimer’s Test, a urine-based diagnostic platform designed to aid in the diagnosis of Alzheimer’s disease using urinary volatile organic compound (VOC) analysis. The milestone represents a major advancement for non-invasive neurological diagnostics and further validates the growing role of artificial intelligence and volatilomics in disease detection.
The FDA designation recognizes the test’s potential to address a major unmet medical need in cognitive evaluation and Alzheimer’s disease diagnosis through a simple urine sample rather than invasive or expensive procedures. TOBY stated that the test analyzes urinary VOC patterns using advanced mass spectrometry combined with proprietary machine learning algorithms to identify molecular signatures associated with Alzheimer’s disease. Company executives emphasized that the platform is designed to improve accessibility to earlier cognitive assessment while reducing reliance on imaging scans, spinal fluid testing, or specialist-only diagnostic procedures.
Urine-Based Diagnostics Offer New Alzheimer’s Detection Approach
Alzheimer’s disease remains one of the most challenging and rapidly growing neurological disorders worldwide, with millions of patients facing delayed diagnosis due to the complexity, cost, and limited accessibility of current testing methods. Existing diagnostic strategies frequently depend on specialist neurological evaluations, PET imaging, cerebrospinal fluid testing, or newly emerging blood-based biomarker technologies.
TOBY’s investigational platform introduces a fundamentally different diagnostic approach centered on non-invasive urinary VOC analysis. According to the company, the proposed indication recognized by the FDA would allow the TOBY Alzheimer’s Test to aid in diagnosis of Alzheimer’s disease in adults aged 50 years and older who present with signs and symptoms of cognitive impairment and are undergoing evaluation for possible Alzheimer’s disease. The company noted that test results are intended to be interpreted alongside additional clinical information as part of a broader diagnostic workup.
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Matthew Laskowski, Founder and Chief Executive Officer of TOBY, stated that the FDA designation further validates urinary VOC patterns as an entirely new diagnostic modality with the potential to improve accessibility and convenience in Alzheimer’s disease evaluation. He emphasized that millions of patients and families affected by cognitive decline continue facing significant barriers to obtaining earlier answers and timely clinical assessment.
The company also highlighted that most currently cleared or breakthrough-designated Alzheimer’s diagnostics focus primarily on detecting amyloid pathology associated with the disease, whereas TOBY’s proposed indication is specifically designed to aid in diagnosis of Alzheimer’s disease itself. The organization believes this broader disease-oriented approach may help support future advancements in large-scale cognitive screening and earlier intervention strategies.
FDA Breakthrough Program Accelerates Diagnostic Innovation
The FDA’s Breakthrough Devices Program is intended to accelerate development and regulatory review for technologies that may provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. The designation enables TOBY to engage more closely with FDA reviewers throughout product development and future regulatory submissions.
TOBY confirmed that it plans to continue additional clinical validation studies while working with the FDA to advance the Alzheimer’s test toward potential commercialization. The latest designation marks the company’s third FDA Breakthrough Device Designation, further expanding its development portfolio across oncology and central nervous system (CNS) disease applications.
Industry analysts believe regulatory support for non-invasive diagnostics is increasing rapidly as healthcare systems seek scalable technologies capable of improving earlier disease detection while reducing procedural burden and healthcare costs. Alzheimer’s disease diagnostics have become a major focus area within precision medicine and neurodegenerative disease research as aging global populations continue driving rising dementia prevalence.
AI and Volatilomics Expand Future of Disease Detection
Founded in 2023, TOBY is building a broader disease detection platform centered on volatilomics, mass spectrometry, and artificial intelligence. The company’s technology is designed to identify disease-specific molecular signatures from a single non-invasive urine sample, potentially enabling scalable diagnostic applications across multiple therapeutic areas.
The organization stated that its long-term mission is to make early disease detection more routine, accessible, and precise through AI-driven molecular diagnostics. Industry experts believe volatilomics may emerge as an important new frontier in biomarker science because volatile organic compounds can reflect complex metabolic and biochemical changes associated with disease progression.
As healthcare systems continue prioritizing earlier intervention in neurodegenerative diseases, non-invasive AI-powered diagnostics such as TOBY’s urine-based platform may play an increasingly important role in expanding patient access to cognitive evaluation and supporting future precision medicine strategies for Alzheimer’s disease and other neurological disorders.
Source: TOBY press release
