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BOSTON, June 23, 2025 /<a data-mce-href="https://www.prnewswire.com/news-releases/toby-completes-nashville-entrepreneur-centers-project-healthcare-accelerator-302505797.html?tc=eml_cleartime" href="https://www.prnewswire.com/news-releases/toby-completes-nashville-entrepreneur-centers-project-healthcare-accelerator-302505797.html?tc=eml_cleartime" title="View official press release on PR Newswire" target="_blank" rel="noopener" data-mce-selected="inline-boundary">PRNewswire</a>/ -- TOBY, Inc., a leader in noninvasive multi-cancer detection, has successfully completed the Nashville Entrepreneur Center’s Project Healthcare accelerator. This four-month program, known for its deep integration with Nashville’s healthcare ecosystem, provided TOBY with strategic mentorship, industry connections, and access to key stakeholders, enhancing its readiness for market entry.Project Healthcare, now in its seventh year, is designed to support high-growth healthcare startups by offering a tailored curriculum and connections to Nashville's extensive network of healthcare organizations, including seven of the nation's largest health systems. As an HCA Healthcare Scholar in the cohort, TOBY's participation in this program has been influential in refining its go-to-market strategy and expanding its network within the healthcare industry."Project Healthcare provided us with access to healthcare leaders and insights that have been critical in shaping our commercialization strategy," said Matthew Laskowski, CEO of TOBY. "The program's emphasis on real-world application and industry immersion has positioned us to effectively bring our innovative cancer detection solution to the market."TOBY's platform utilizes advanced gas chromatography–mass spectrometry and proprietary AI models to analyze volatile organic compounds (VOCs) in urine, enabling the detection of multiple cancers with high sensitivity and specificity. This noninvasive approach offers a patient-friendly alternative to traditional screening methods."TOBY is exactly the kind of company we seek to enroll in Project Healthcare. Matthew and his team leveraged our resources and curriculum to further the success they had already built prior to working with us," said Sam Davidson, chief executive officer, Nashville Entrepreneur Center. "We're excited to see where they go next as they continue to innovate within the industry."With the completion of Project Healthcare, TOBY is poised to advance its clinical validation studies and submissions, bringing its innovative cancer detection solution closer to widespread clinical adoption.In addition to Project Healthcare, TOBY participated in the MassChallenge U.S. Early Stage Accelerator and the LifeX Life Sciences Commercialization Accelerator. The company also earned the Massachusetts AI Health Innovation Grant, where the Cambridge Innovation Center (CIC) assisted in software development efforts, was selected for McDermott Will &amp; Emery’s competitive LEAP Program, and won first prize at ADLM 2024, placing it first among nearly 100 biotech startups.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.:</h3>TOBY, inspired by after 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">Investors@Toby.health</a>

TOBY Completes Nashville Entrepreneur Center’s Project Healthcare Accelerator

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>

TOBY Urine Test completes participation in 2025 Mayo Clinic and ASU Alliance for Health Care MedTech Accelerator

TOBY

Cancer screening test

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Cabin

<a title="Read full article" href="https://www.toby.health/blog/fda-grants-breakthrough-device-designation-to-toby-s-ai-powered-urine-test-for-early-bladder-cancer-detection">TOBY Granted FDA Breakthrough Device Designation</a>

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TOBY Completes Nashville Entrepreneur Center’s Project He...

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

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