FDA Grants Breakthrough Device Designation to Urine Test for Early Bladder Cancer Detection

Boston: TOBY, Inc., a biotech startup advancing non-invasive cancer detection through urine-based volatilomics and Artificial Intelligence, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its TOBY Test for Bladder Cancer.

"This designation validates the potential of our one-step urine test to detect bladder cancer at its most treatable stage," said Matthew Laskowski, chief executive officer 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."

Bladder cancer is the sixth most common cancer in the U.S. yet remains one of the costliest to manage due to its high recurrence and reliance on invasive surveillance tools like cystoscopy. TOBY's test provides a painless, low-cost alternative-analyzing volatile organic compounds (VOCs) in a single urine sample using gas chromatography-mass spectrometry and proprietary AI to generate a real-time cancer risk score.

The FDA's Breakthrough Devices Program offers more frequent interactions with FDA and prioritized submission review for technologies that provide 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."

TOBY is also preparing for multi-cancer clinical studies to validate the platform's accuracy, generalizability, and clinical value—laying the groundwork for large-scale screening based on VOC biomarkers and AI.