“This Breakthrough Device Designation marks a defining moment for TOBY and for the future of cancer screening,” said Matthew Laskowski, Chief Executive Officer of TOBY. “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.