TOBY Earns FDA Breakthrough Designation for Its Urine-Based Alzheimer’s Test

The U.S. Food and Drug Administration has granted Breakthrough Device Designation to TOBY Inc. for its urine-based Alzheimer’s disease test.

The TOBY Alzheimer’s Test is designed to help diagnose Alzheimer’s disease using urinary volatile organic compound (VOC) patterns analyzed through mass spectroscopy and proprietary machine learning algorithms.

“This designation further validates the potential of urinary VOC patterns as an entirely new diagnostic modality,” TOBY Founder/CEO Matthew Laskowski said. “For the millions of individuals and families living in the shadow of Alzheimer’s disease, the need for earlier, simpler, and more accessible detection has never been greater. This milestone reflects our commitment to the patients and families who deserve earlier and easier answers.”

Alzheimer’s disease remains one of the most significant unmet needs in medicine, with diagnosis often dependent on specialist evaluation, imaging, cerebrospinal fluid testing, or emerging blood-based biomarkers. TOBY is developing a fundamentally different approach centered on non-invasive urinary VOC analysis.

Under the proposed indication recognized by the FDA, the TOBY Alzheimer’s Test is intended to help diagnose Alzheimer’s disease in adults aged 50 years and older who show signs and symptoms of cognitive impairment and are undergoing evaluation for Alzheimer’s disease. Test results are intended to be interpreted alongside other clinical information.

“Existing cleared and breakthrough-designated Alzheimer’s tests are generally focused on identifying amyloid pathology associated with Alzheimer’s disease, whereas the proposed indication for the TOBY Alzheimer’s Test is intended to aid in the diagnosis of Alzheimer’s disease itself,” Laskowski stated. “Our goal is to build scalable, non-invasive tests capable of transforming how serious diseases are detected and evaluated.”

The Alzheimer’s designation is TOBY’s third FDA Breakthrough Device Designation, expanding its portfolio across oncology and central nervous system (CNS) disease and reinforcing the company’s broader platform strategy around urine-based molecular diagnostics.

The FDA’s Breakthrough Devices Program is designed to accelerate the development and review of technologies that may provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. The designation enables TOBY to work more closely with the FDA throughout the development and regulatory review process. TOBY plans to continue clinical validation studies and work closely with the FDA toward future regulatory submissions.

Founded in 2023 and named after Sherlock Holmes’s trusted bloodhound, TOBY is pioneering urine-based detection using volatilomics, mass spectrometry, and artificial intelligence. Its platform is designed to detect disease from a single non-invasive urine sample. TOBY’s mission is to make the early detection of disease routine, accessible, and precise.