FDA grants Breakthrough Device Designation to urine-based multi-cancer early detection test

The FDA has granted Breakthrough Device Designation to TOBY’s urine-based multi-cancer early detection (MCED) test, TOBY, Inc announced.¹

The assay is designed to detect multiple cancers, including prostate, bladder, and kidney cancer, through a simple, non-invasive urine sample.² The MCED platform analyzes volatile organic compounds (VOCs) in urine using spectroscopy and machine learning to identify cancer-associated molecular patterns, offering an alternative to blood-based screening approaches.

"This Breakthrough Device Designation marks a defining moment for TOBY and for the future of cancer screening," said Matthew Laskowski, CEO of TOBY, in the company’s news release.¹ "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.”

TOBY reported that the MCED test earned an “excellent” rating in detecting prostate, bladder, and kidney cancer by demonstrating an area under the curve greater than 0.9 in internal validation assessments. The test was also rated as “excellent” across all other cancer types assessed.²

Breakthrough Device Designation is intended to expedite development and regulatory review for technologies that may provide significant advantages over current options for serious conditions. With this designation, the development process for TOBY’s MCED test can benefit from more frequent FDA guidance, as well as priority review.

"The FDA reserves Breakthrough Device Designation for platforms that can fundamentally change patient outcomes, not incremental improvements on what already exists," said Matthew Collier, CEO of TOBY Oncology, in the news release from the company.¹ "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 builds on prior regulatory recognition of its urine-based bladder cancer test, which also received Breakthrough Device Designation in June 2025. The company reports that its broader MCED platform is intended to detect more than 10 cancers representing a majority of global cancer incidence.

Laskowski concluded, “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."

REFERENCES

1. TOBY Receives FDA Breakthrough Device Designation for Its Urine-Based Multi-Cancer Early Detection (MCED) Test. News release. TOBY, Inc. April 14, 2026. Accessed April 14, 2026. https://www.toby.health/blog/toby-receives-fda-breakthrough-device-designation-for-its-urine-based-multi-cancer-early-detection--mced--test

2. TOBY Oncology. TOBY, Inc. Accessed April 14, 2026. https://www.toby.health/platform/toby-oncology