Toby, a biotechnology company developing non-invasive cancer screening technologies, said the FDA has granted Breakthrough Device Designation to its urine-based Multi-Cancer Early Detection (MCED) test.
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," said Matthew Collier, Chief Executive Officer of TOBY Oncology. "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 said its 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.
