FDA Grants Breakthrough Device Designation to Urine-Based Alzheimer's Test and Xylazine Rapid Test

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to two diagnostic tests: TOBY Inc.'s urine-based Alzheimer's disease test and Instanosis Inc.'s Xylazine Rapid Test (Urine). Both designations recognize the potential of these technologies to address unmet needs in their respective areas of diagnosis.

TOBY Inc announced that the FDA granted Breakthrough Device Designation to its urine-based Alzheimer's disease diagnostic test, known as the TOBY Test for Alzheimer's Disease. 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.

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, according to the company's founder and CEO. 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.

Separately, Instanosis Inc. announced that its Xylazine Rapid Test (Urine) has been granted Breakthrough Device Designation by the FDA. Xylazine, a veterinary sedative not approved for human use, has become increasingly prevalent in the illicit drug supply across the United States. It is frequently identified in combination with fentanyl and other synthetic opioids and has been associated with severe respiratory depression, prolonged sedation, and complex soft tissue injury. Because naloxone does not reverse the effects of xylazine, identifying its presence is critical for informing clinical assessment and patient monitoring.

The Instanosis Xylazine Rapid Test (Urine) is designed to provide rapid detection of xylazine in urine samples. The device is intended to support healthcare providers, laboratories, and public health professionals in identifying potential exposure and improving awareness of evolving substance patterns. Through this designation, Instanosis will receive prioritized interaction and review as the company advances the device through its regulatory pathway.