The test uses urinary volatile organic compound patterns and machine learning to aid in the diagnosis of Alzheimer’s disease.
TOBY Inc announced that the Food and Drug Administration (FDA) granted Breakthrough Device Designation to its urine-based Alzheimer’s disease diagnostic test. The designation recognizes the potential of the TOBY Test for Alzheimer’s Disease to aid in diagnosis through a non-invasive urine sample, addressing a need for accessible cognitive evaluation and diagnostic care.
The test identifies urinary volatile organic compound (VOC) patterns, which are analyzed using mass spectroscopy and machine learning algorithms. Under the proposed indication recognized by the FDA, the test is intended for use in adults aged 50 years and older who show signs and symptoms of cognitive impairment and are undergoing evaluation for Alzheimer’s disease. Results are meant to be interpreted alongside other clinical information.
“This designation further validates the potential of urinary VOC patterns as an entirely new diagnostic modality,” says Matthew Laskowski, founder and CEO of TOBY, in a release. “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.”
While existing cleared and breakthrough-designated tests often focus on identifying amyloid pathology associated with the disease, the TOBY Alzheimer’s Test is intended to aid in the diagnosis of Alzheimer’s disease itself, says Laskowski in a release. “Our goal is to build scalable, non-invasive tests capable of transforming how serious diseases are detected and evaluated,” says Laskowski in a release.
This milestone represents the third FDA Breakthrough Device Designation for the company, which is also developing urine-based molecular diagnostics for oncology and central nervous system diseases.
The FDA Breakthrough Devices Program is intended to accelerate the development and review of technologies that provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. The designation allows TOBY to work more closely with the agency during the development and regulatory review process. The company plans to continue clinical validation studies and work with the FDA toward future regulatory submissions.
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