TOBY's Revolutionary Urine Test Receives FDA Breakthrough Device Designation for Multi-Cancer Detection
On April 14, 2026, TOBY, Inc., a trailblazer in biotechnology known for its focus on non-invasive cancer screening technologies, announced a monumental achievement: the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for TOBY's innovative urine-based Multi-Cancer Early Detection (MCED) test. This designation is a clear recognition of the test's potential to enable the early detection of several types of cancers using a simple, non-invasive urine sample. Early detection remains one of the most critical factors in improving cancer outcomes, and TOBY's advancement addresses a significant gap in the current cancer screening landscape.
Matthew Laskowski, CEO of TOBY, expressed that this designation represents a pivotal moment for both the company and the future of cancer screening as a whole. He emphasized that urine-based, non-invasive detection holds the promise to transform the way cancer is diagnosed, leading to improved patient experiences by allowing for earlier and more widespread screenings. Laskowski mentioned that the next era of cancer detection would focus on user-friendly approaches accessible to broader populations, breaking away from the limitations of existing screening methods. The platform developed by TOBY is engineered with this vision, supporting multi-cancer detection from a single urine sample, a game-changer in the battle against this disease.
The technology behind TOBY's MCED platform is grounded in cutting-edge scientific principles, utilizing volatile organic compounds (VOCs) found in urine. The platform employs sophisticated techniques, including spectroscopy and machine learning algorithms, to identify molecular patterns associated with cancer. By requiring only a single urine sample, this test offers a viable alternative to conventional blood-based screening methods, making it a more convenient and scalable option for population screening.
Matthew Collier, CEO of TOBY Oncology, remarked that the FDA's Breakthrough Device Designation is reserved for platforms capable of fundamentally enhancing patient outcomes—not merely improving upon existing technologies. The test aims to provide early-stage accuracy combined with enhanced affordability and broad accessibility to improve cancer screening timelines. Collier highlighted that this designation accelerates TOBY's journey to serve patients and healthcare systems that need more effective cancer detection solutions.
TOBY's MCED technology marks a historic first as the first urine-based multi-cancer early detection platform to receive the FDA's Breakthrough Device Designation. This program is specifically designed to expedite the development and review of innovative medical devices that promise more effective diagnoses or therapies for serious and life-threatening conditions. Notably, this achievement builds upon a previous Breakthrough Device Designation awarded to TOBY for its urine-based bladder cancer test. The MCED platform aims to detect a significant portion of cancers, including those that represent the bulk of global cancer incidences.
This designation not only strengthens TOBY's ambitions for further clinical studies and regulatory submissions but also aligns with the company's goals to secure reimbursement strategies as it continues its journey toward broad clinical adoption. The company is committed to validating its technologies in close collaboration with the FDA to create the necessary evidence that will support expansive use in typical healthcare settings.
Founded in 2023 and named after Sherlock Holmes's renowned bloodhound, TOBY is dedicated to elevating the standards of cancer screening by harnessing the principles of volatilomics, advanced spectroscopy, and artificial intelligence. The firm specializes in developing methods capable of detecting over ten types of cancers through a single, non-invasive urine sample, targeting a significant global public health concern. TOBY has set the ambitious goal of making early cancer detection routine, accessible, and precise for everyone. To learn more about TOBY and its groundbreaking technologies, visit Toby.health.
Matthew Laskowski, CEO of TOBY, expressed that this designation represents a pivotal moment for both the company and the future of cancer screening as a whole. He emphasized that urine-based, non-invasive detection holds the promise to transform the way cancer is diagnosed, leading to improved patient experiences by allowing for earlier and more widespread screenings. Laskowski mentioned that the next era of cancer detection would focus on user-friendly approaches accessible to broader populations, breaking away from the limitations of existing screening methods. The platform developed by TOBY is engineered with this vision, supporting multi-cancer detection from a single urine sample, a game-changer in the battle against this disease.
The technology behind TOBY's MCED platform is grounded in cutting-edge scientific principles, utilizing volatile organic compounds (VOCs) found in urine. The platform employs sophisticated techniques, including spectroscopy and machine learning algorithms, to identify molecular patterns associated with cancer. By requiring only a single urine sample, this test offers a viable alternative to conventional blood-based screening methods, making it a more convenient and scalable option for population screening.
Matthew Collier, CEO of TOBY Oncology, remarked that the FDA's Breakthrough Device Designation is reserved for platforms capable of fundamentally enhancing patient outcomes—not merely improving upon existing technologies. The test aims to provide early-stage accuracy combined with enhanced affordability and broad accessibility to improve cancer screening timelines. Collier highlighted that this designation accelerates TOBY's journey to serve patients and healthcare systems that need more effective cancer detection solutions.
TOBY's MCED technology marks a historic first as the first urine-based multi-cancer early detection platform to receive the FDA's Breakthrough Device Designation. This program is specifically designed to expedite the development and review of innovative medical devices that promise more effective diagnoses or therapies for serious and life-threatening conditions. Notably, this achievement builds upon a previous Breakthrough Device Designation awarded to TOBY for its urine-based bladder cancer test. The MCED platform aims to detect a significant portion of cancers, including those that represent the bulk of global cancer incidences.
This designation not only strengthens TOBY's ambitions for further clinical studies and regulatory submissions but also aligns with the company's goals to secure reimbursement strategies as it continues its journey toward broad clinical adoption. The company is committed to validating its technologies in close collaboration with the FDA to create the necessary evidence that will support expansive use in typical healthcare settings.
Founded in 2023 and named after Sherlock Holmes's renowned bloodhound, TOBY is dedicated to elevating the standards of cancer screening by harnessing the principles of volatilomics, advanced spectroscopy, and artificial intelligence. The firm specializes in developing methods capable of detecting over ten types of cancers through a single, non-invasive urine sample, targeting a significant global public health concern. TOBY has set the ambitious goal of making early cancer detection routine, accessible, and precise for everyone. To learn more about TOBY and its groundbreaking technologies, visit Toby.health.
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