FDA Breakthrough Designation Granted to Urine-Based Multi-Cancer Early Detection Test

TOBY Inc. has earned U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its urine-based Multi-Cancer Early Detection (MCED) test, which aims to enable earlier detection of multiple cancers through a simple, non-invasive urine sample.

“This Breakthrough Device Designation marks a defining moment for TOBY and for the future of cancer screening,” TOBY CEO Matthew Laskowski said. “It reinforces our conviction that urine-based, non-invasive detection can fundamentally change how and when cancer is identified, not just by improving the patient experience, but by enabling screening to happen earlier and at scale. We believe the next generation of cancer detection will be built around approaches that are simple, accessible, and designed for broad population use, rather than constrained by the limitations of existing modalities, and our platform is engineered with that vision in mind, supporting multi-cancer detection from a single sample. Working closely with the FDA, we are now positioned to accelerate clinical validation and generate the evidence required to bring a more scalable, widely accessible approach to early cancer detection into routine care.”

TOBY’s MCED platform analyzes volatile organic compounds (VOCs) in urine using spectroscopy and machine learning to identify cancer-associated molecular patterns. The test requires only a single urine sample, offering an alternative to blood-based screening approaches while supporting scalable population screening.

“The FDA reserves Breakthrough Device Designation for platforms that can fundamentally change patient outcomes, not incremental improvements on what already exists,” TOBY Oncology CEO Matthew Collier said. “A single, non-invasive urine sample that aims to deliver on the necessary early stage accuracy, improved affordability, and broadly available accessibility to enable screening for many cancers is exactly that kind of platform, and this designation accelerates our path to the patients and health systems that need it most.”

TOBY’s platform is the first urine-based MCED technology to receive FDA Breakthrough Device Designation, a program designed to expedite the development and review of medical devices that provide more effective diagnosis or treatment of serious or life-threatening diseases, and builds on the FDA’s previous Breakthrough Device Designation granted to TOBY for its urine-based bladder cancer test. The platform is designed to detect many cancers from a single sample, representing the majority of global cancer incidence. The designation supports TOBY’s continued progress toward expanded clinical studies, future regulatory submissions, and reimbursement, as the company advances further validation while working closely with the FDA to establish the evidence required for broad clinical adoption.

Founded in 2023 and named after Sherlock Holmes’s trusted bloodhound, TOBY is pioneering urine-based cancer screening using volatilomics, spectroscopy, and artificial intelligence. Its platform is designed to detect more than 10 cancers from a single non-invasive sample, representing the majoirty of global cancer cases. TOBY received FDA Breakthrough Device Designation for its urine-based MCED technology and its urine-based bladder cancer test. TOBY’s mission is to make early detection routine, accessible, and precise.