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BOSTON, June 30, 2025 /<a data-mce-href="https://www.prnewswire.com/news-releases/fda-grants-breakthrough-device-designation-to-tobys-ai-powered-urine-test-for-early-bladder-cancer-detection-302493602.html" href="https://www.prnewswire.com/news-releases/fda-grants-breakthrough-device-designation-to-tobys-ai-powered-urine-test-for-early-bladder-cancer-detection-302493602.html" title="View official press release on PR Newswire" target="_blank" rel="noopener">PRNewswire</a>/ -- TOBY, Inc., a biotech startup advancing non-invasive cancer detection through urine-based volatilomics and Artificial Intelligence, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its TOBY Test for Bladder Cancer."This designation validates the potential of our one-step urine test to detect bladder cancer at its most treatable stage," said Matthew Laskowski, chief executive officer of TOBY. "We now have a unique opportunity to work more closely with the FDA, accelerate our clinical development, and make early, accessible, and affordable cancer screening a reality."Bladder cancer is the sixth most common cancer in the U.S. yet remains one of the costliest to manage due to its high recurrence and reliance on invasive surveillance tools like cystoscopy. TOBY's test provides a painless, low-cost alternative—analyzing volatile organic compounds (VOCs) in a single urine sample using gas chromatography–mass spectrometry and proprietary AI to generate a real-time cancer risk score.The FDA's Breakthrough Devices Program offers more frequent interactions with FDA and prioritized submission review for technologies that provide significant advantages over current standards of care."This milestone is a leap forward not only for TOBY but for the patients and clinicians we aim to serve," said Laskowski. "We founded TOBY to uncover what conventional methods often miss. With FDA's support, we're one step closer to making early cancer detection effortless and accessible for everyone."TOBY is also preparing for multi-cancer clinical studies to validate the platform's accuracy, generalizability, and clinical value—laying the groundwork for large-scale screening based on VOC biomarkers and AI.To learn more, visit <a data-mce-href="http://www.toby.health" href="http://www.toby.health">Toby.health</a>.<h3>About TOBY, Inc.:&nbsp;</h3>Founded in 2023 and named after Sherlock Holmes's trusted bloodhound, TOBY is pioneering urine-based cancer screening using volatilomics and artificial intelligence. Its platform is designed to detect more than ten cancers from a single non-invasive sample—representing over 60% of global cancer cases. TOBY's mission is to make early detection routine, accessible, and precise. SOURCE TOBY, Inc. Media Contact: <a data-mce-href="mailto:Press@Toby.health" href="mailto:Press@Toby.health" title="Email the TOBY press team">Press@Toby.health</a>Investor Contact: <a data-mce-href="mailto:Investors@toby.health" href="mailto:Investors@toby.health" title="Email the TOBY investor team">Investors@Toby.health</a>

FDA Grants Breakthrough Device Designation to TOBY's AI-Powered Urine Test for Early Bladder Cancer Detection

BOSTON, June 23, 2025 /<a data-mce-href="https://www.prnewswire.com/news-releases/toby-urine-test-completes-participation-in-2025-mayo-clinic-and-asu-alliance-for-health-care-medtech-accelerator-302488354.html?tc=eml_cleartime" href="https://www.prnewswire.com/news-releases/toby-urine-test-completes-participation-in-2025-mayo-clinic-and-asu-alliance-for-health-care-medtech-accelerator-302488354.html?tc=eml_cleartime" target="_blank" title="View official press release on PR Newswire" rel="noopener">PRNewswire</a>/ -- TOBY, Inc., a biotechnology company focusing on improving early cancer screening, today announced its completion of its participation in the Mayo Clinic and Arizona State University Alliance for Health Care MedTech Accelerator in Phoenix, AZ. Out of a global pool of applicants, only ten companies were selected for the 2025 cohort.&nbsp;TOBY is developing a noninvasive urine spectroscopy and Artificial Intelligence (AI) platform for early cancer detection. The technology analyzes unique molecular signatures to support early, accessible, and cost-effective screening using a urine test.The Mayo Clinic and Arizona State University MedTech Accelerator supports early-stage medical technology companies through access to clinical, academic, and commercial resources. Participating companies receive mentorship and strategic guidance during the program and remain connected through the MedTech Accelerator network."There is a critical need for screening methods that are accessible and affordable," said Matthew Laskowski, Chief Executive Officer of TOBY. "Participation in the MedTech Accelerator has been instrumental in advancing our technology and development strategy."According to the International Agency for Research on Cancer (IARC), global cancer incidence is projected to rise significantly between 2022 and 2045. In the United States, the National Cancer Institute estimates that over 2 million people will be diagnosed with cancer in 2025."Our goal is to support earlier detection, when treatment is most effective and the burden on patients and the healthcare system is reduced," said Dragan Sebišanović, Chief Science Officer of TOBY. "Our technology uses machine learning to help identify molecular patterns associated with early-stage cancer."To learn more, visit <a data-mce-href="http://www.toby.health" href="http://www.toby.health" title="Visit Toby’s homepage">Toby.health</a>. <h3>About TOBY, Inc.:&nbsp;</h3>TOBY, inspired by Sherlock Holmes's Bloodhound, is a BioTech startup focused on the early detection of cancer utilizing spectroscopy and Artificial Intelligence. TOBY has developed a single urine test that detects 10 cancers, representing over 60% of all new cases globally. This test identifies the unique molecular signature of cancer by combining the precision of spectroscopy, changes in biomarkers (VOCs), and cutting-edge computational algorithms to deliver early, easy, and affordable cancer screening.SOURCE TOBY, Inc.Media Contact: <a data-mce-href="mailto:Press@Toby.health" href="mailto:Press@Toby.health" title="Email the TOBY press team">Press@Toby.health</a>Investor Contact: <a data-mce-href="mailto:Investors@toby.health" href="mailto:Investors@toby.health" title="Email the TOBY investor team" data-mce-selected="inline-boundary">Investors@Toby.health</a>

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FDA Grants Breakthrough Device Designation to TOBY's AI-P...

TOBY Urine Test completes participation in 2025 Mayo Clin...