FDA grants breakthrough device designation to urine test for bladder cancer detection

The FDA has granted a breakthrough device designation to the TOBY Test, an artificial intelligence (AI)-powered urine test for early detection of bladder cancer, TOBY, Inc announced in a news release.¹

The company also announced plans to initiate multi-cancer clinical studies of the test.

Breakthrough device designations are intended to support the development of technologies that have the potential to provide significant advantages over current options. With this designation, the development process for the TOBY test can benefit from more frequent FDA guidance, as well as priority review.

"This designation validates the potential of our 1-step urine test to detect bladder cancer at its most treatable stage," said Matthew Laskowski, chief executive officer of TOBY, in the news release from the company.¹ "We now have a unique opportunity to work more closely with the FDA, accelerate our clinical development, and make early, accessible, and affordable cancer screening a reality."

The TOBY test works by analyzing the molecular signatures of volatile organic compounds in urine using gas chromatography–mass spectrometry and proprietary AI.

According to the company, “These signatures reflect real-time changes in physiology and metabolism. Our proprietary AI interprets this complex data to identify early patterns of disease, often before symptoms appear.”²

Using these data, the test then generates a cancer risk score from a single urine sample, with the ability to detect more than 10 cancers.

TOBY reported that the test earned an “excellent” rating in detecting bladder cancer by demonstrating an area under the curve greater than 0.9 in internal validation assessments. The test was also rated as “excellent” across all other cancer types assessed, including prostate and kidney cancer.³

The company reported plans to initiate multi-cancer clinical studies to validate the platform’s accuracy, generalizability, and value in clinical practice.

"This milestone is a leap forward not only for TOBY but for the patients and clinicians we aim to serve," Laskowski added in the news release.¹ "We founded TOBY to uncover what conventional methods often miss. With FDA's support, we're one step closer to making early cancer detection effortless and accessible for everyone."

REFERENCES

1. FDA grants Breakthrough Device Designation to TOBY's AI-powered urine test for early bladder cancer detection. News release. TOBY, Inc. Published online and accessed June 30, 2025. https://www.prnewswire.com/news-releases/fda-grants-breakthrough-device-designation-to-tobys-ai-powered-urine-test-for-early-bladder-cancer-detection-302493602.html

2. Technology. TOBY. Accessed June 30, 2025. https://www.toby.health/technology

3. Pipeline. TOBY. Accessed June 30, 2025. https://www.toby.health/product