Urine-Based Alzheimer’s Test Receives FDA Breakthrough Device Designation

The TOBY Test for Alzheimer’s Disease from TOBY, Inc. (Austin, TX, USA) has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation as an aid in the diagnosis of Alzheimer’s disease. The non-invasive test uses a simple urine sample and is intended for evaluating adults aged 50 years and older who have signs and symptoms of cognitive impairment. Under the proposed indication recognized by the agency, results are intended to be interpreted alongside other clinical information. The designation reflects the test’s potential to address unmet needs in accessible cognitive evaluation and diagnostic care.

The assay assesses patterns of urinary volatile organic compounds using mass spectrometry combined with proprietary machine learning algorithms. By targeting disease-associated urinary VOC signatures, the approach provides a distinctly non-invasive pathway for aiding diagnosis. In contrast to modalities that focus primarily on detecting amyloid pathology, the proposed indication for this test is to aid in the diagnosis of Alzheimer’s disease itself.

The Breakthrough Devices Program is intended to accelerate development and review of technologies that may offer more effective diagnosis or treatment for life‑threatening or irreversibly debilitating conditions. The designation enables closer interaction with the FDA throughout development and regulatory review. TOBY plans to continue clinical validation studies and work with the agency toward future regulatory submissions. This Alzheimer’s designation is the company’s third Breakthrough Device Designation, reinforcing its platform strategy in urine-based molecular diagnostics across oncology and central nervous system disease.

"This designation further validates the potential of urinary VOC patterns as an entirely new diagnostic modality," said Matthew Laskowski, Founder and CEO of TOBY. "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."

"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. Our goal is to build scalable, non-invasive tests capable of transforming how serious diseases are detected and evaluated," said Laskowski.