TOBY's Urine-Based Multi-Cancer Detection Test Receives FDA Breakthrough Device Designation
Key Insights
TOBY (search)'s urine-based Multi-Cancer Early Detection (MCED) test has received FDA Breakthrough Device Designation, marking the first urine-based MCED technology to achieve this status.
The platform analyzes volatile organic compounds in urine using spectroscopy and machine learning to identify cancer-associated molecular patterns from a single sample.
The designation accelerates development and review processes, positioning TOBY (search) to advance clinical validation and bring scalable early cancer detection to routine care.
TOBY (search), Inc., a biotechnology company developing non-invasive cancer screening technologies, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its urine-based Multi-Cancer Early Detection (MCED) test. The designation recognizes the test's potential to enable earlier detection of multiple cancers through a simple, non-invasive urine sample and address a major unmet need in cancer screening.
The FDA's Breakthrough Device Designation is reserved for medical devices that provide more effective diagnosis or treatment of serious or life-threatening diseases. TOBY (search)'s platform represents the first urine-based MCED technology to receive this designation, building on the FDA's previous Breakthrough Device Designation granted to TOBY for its urine-based bladder cancer test.
Revolutionary Detection Technology
TOBY (search)'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 platform incorporates spectroscopy, a technology that uses light waves to determine the composition of matter, to detect cancer-related molecules. By incorporating machine learning, the assay can predict the presence of cancer-associated patterns, thus identifying patients at high risk of cancer who should receive advanced diagnostic testing.
Clinical and Commercial Implications
"This Breakthrough Device Designation marks a defining moment for TOBY (search) 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."
The platform is designed to detect many cancers from a single sample, representing the majority of global cancer incidence. TOBY (search)'s platform includes a non-invasive screen for multiple cancer types, including prostate, bladder, and kidney cancers, from a single urine sample.
Addressing Healthcare Gaps
MCED technology could help fill important gaps in cancer care. Non-invasive screening tests may offer a more affordable way to find cancer early, when more treatments are possible. Because these tests are simple, they could also reach more patients.
"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 (search) 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."
Regulatory Pathway Forward
The Breakthrough Devices Program provides patients with quicker access to medical devices by accelerating development, assessment, and review. The designation supports TOBY (search)'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.
"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," Collier added.