TOBY Wins FDA Breakthrough Status for AI-Powered Urine Test for Bladder Cancer

TOBY, a biotech startup focused on non-invasive cancer detection through urine-based volatilomics and artificial intelligence (AI), has earned U.S. Food and Drug Administration (FDA) breakthrough device status for its TOBY test for bladder cancer.

Bladder cancer is one of the costliest cancers to manage because of its high recurrence and reliance on invasive surveillance tools like cystoscopy. TOBY’s test analyzes volatile organic compounds (VOCs) in a single urine sample using gas chromatography, mass spectrometry, and AI to create a real-time cancer risk score.

The company is preparing for multi-cancer clinical studies to validate the platform’s accuracy, generalizability, and clinical value. This lays the groundwork for large-scale screening based on VOC biomarkers and AI.

“This designation validates the potential of our one-step urine test to detect bladder cancer at its most treatable stage,” said Matthew Laskowski, CEO of TOBY. “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 FDA’s Breakthrough Devices Program provides more frequent communication with the FDA and prioritized submission review for tech that offers significant advantages over current standards of care.

“This milestone is a leap forward not only for TOBY but for the patients and clinicians we aim to serve,” said Laskowski. “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.”