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&nbsp; AUSTIN, May 26, 2026 /<a data-mce-href="https://www.prnewswire.com/news-releases/toby-receives-fda-breakthrough-device-designation-for-its-urine-based-alzheimers-disease-diagnostic-test-302779627.html" href="https://www.prnewswire.com/news-releases/toby-receives-fda-breakthrough-device-designation-for-its-urine-based-alzheimers-disease-diagnostic-test-302779627.html" title="View official press release on PR Newswire" target="_blank" rel="noopener">PRNewswire</a>/ -- TOBY, Inc., a biotechnology company developing non-invasive disease detection technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the TOBY Test for Alzheimer's Disease. The designation recognizes the test's potential to aid in the diagnosis of Alzheimer's disease through a simple, non-invasive urine sample and address a major unmet need in accessible cognitive evaluation and diagnostic care.The TOBY Alzheimer's Test is designed to aid in the diagnosis of Alzheimer's disease using urinary volatile organic compound (VOC) patterns analyzed through mass spectroscopy and proprietary machine learning algorithms."This designation further validates the potential of urinary VOC patterns as an entirely new diagnostic modality," said Matthew Laskowski, Founder and CEO of TOBY. "For the millions of individuals and families living in the shadow of Alzheimer's disease, the need for earlier, simpler and more accessible detection has never been greater. This milestone reflects our commitment to the patients and families who deserve earlier and easier answers."Alzheimer's disease remains one of the most significant unmet needs in medicine, with diagnosis often dependent on specialist evaluation, imaging, cerebrospinal fluid testing, or emerging blood-based biomarkers. TOBY is developing a fundamentally different approach centered on non-invasive urinary VOC analysis.Under the proposed indication recognized by the FDA, the TOBY Alzheimer's Test is intended to aid in diagnosis of Alzheimer's disease in adults aged 50 years and older who present with signs and symptoms of cognitive impairment and are undergoing evaluation for Alzheimer's disease. Test results are intended to be interpreted alongside other clinical information."Existing cleared and breakthrough-designated Alzheimer's tests are generally focused on identifying amyloid pathology associated with Alzheimer's disease, whereas the proposed indication for the TOBY Alzheimer's Test is intended to aid in the diagnosis of Alzheimer's disease itself," said Laskowski. "Our goal is to build scalable, non-invasive tests capable of transforming how serious diseases are detected and evaluated."The Alzheimer's designation is TOBY's third FDA Breakthrough Device Designation, expanding its portfolio across oncology and central nervous system (CNS) disease and reinforcing the company's broader platform strategy around urine-based molecular diagnostics.The FDA's Breakthrough Devices Program is designed to accelerate the development and review of technologies that may provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. The designation enables TOBY to work more closely with the FDA throughout the development and regulatory review process. TOBY plans to continue clinical validation studies and work closely with the FDA toward future regulatory submissions.To learn more, visit <a data-mce-href="http://www.toby.health" href="http://www.toby.health">Toby.health</a>.<h3>About TOBY, Inc.:</h3>Founded in 2023 and named after Sherlock Holmes's trusted bloodhound, TOBY is pioneering urine-based detection using volatilomics, mass spectrometry, and artificial intelligence. Its platform is designed to detect disease from a single non-invasive urine sample. TOBY's mission is to make the early detection of disease 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>

TOBY Receives FDA Breakthrough Device Designation for Its Urine-Based Alzheimer's Disease Diagnostic Test

AUSTIN, Texas, April 14, 2026 /<a data-mce-href="https://www.prnewswire.com/news-releases/toby-receives-fda-breakthrough-device-designation-for-its-urine-based-multi-cancer-early-detection-mced-test-302741283.html" href="https://www.prnewswire.com/news-releases/toby-receives-fda-breakthrough-device-designation-for-its-urine-based-multi-cancer-early-detection-mced-test-302741283.html" title="View official press release on PR Newswire" target="_blank" rel="noopener">PRNewswire</a>/ -- TOBY, Inc., a biotechnology company developing non-invasive cancer screening technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to TOBY's 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."This Breakthrough Device Designation marks a defining moment for TOBY 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. 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. 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."TOBY's MCED platform analyzes volatile organic compounds (VOCs) in urine using mass spectrometry 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 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 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, and this designation accelerates our path to the patients and health systems that need it most."TOBY's platform is the first urine-based MCED technology to receive FDA Breakthrough Device Designation, a program designed to expedite the development and review of medical devices that provide more effective diagnosis or treatment of serious or life-threatening diseases, and builds on the FDA's previous Breakthrough Device Designation granted to TOBY for its urine-based bladder cancer test. The platform is designed to detect many cancers from a single sample, representing the majority of global cancer incidence. The designation supports TOBY'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.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>

TOBY Receives FDA Breakthrough Device Designation for Its Urine-Based Multi-Cancer Early Detection (MCED) Test

The signing of the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act marks a meaningful shift in U.S. cancer screening policy. For the first time, Medicare has a defined benefit category and a clear pathway to evaluate and potentially cover multi-cancer early detection tests once they receive FDA approval.This change matters because most cancer deaths occur in cancers that lack recommended screening today. While scientific advances have made earlier detection increasingly possible, policy frameworks have lagged behind. By establishing a dedicated pathway, the law gives Medicare the authority to consider MCED tests as preventive care, aligning public policy with emerging capabilities in early cancer detection while preserving rigorous standards for evidence and oversight.At TOBY, we see this as an important step forward for the field. The law now formally establishes a Medicare pathway for multi-cancer early detection, while preserving the need for FDA approval and evidence-based CMS review. What remains is execution. How this pathway is implemented will determine the pace and scope of patient access, but the structural uncertainty that once constrained the field has now been removed by statute. To learn more, visit <a data-mce-href="https://www.toby.health/" href="https://www.toby.health/" title="Visit Toby’s homepage">Toby.health</a>.<h3>About TOBY, Inc.:</h3>TOBY, inspired by Sherlock Holmes's Bloodhound, is a BioTech startup focused on the early detection of cancer utilizing mass spectrometry 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 mass spectrometry, 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>

A Medicare Pathway for Multi-Cancer Early Detection

TOBY has been selected by the American Urological Association (AUA) to present at the 2026 AUA Innovation Nexus Forum, taking place on May 14, 2026, in Washington, DC.The AUA selected 43 innovative companies from around the world to participate in the Forum’s Innovation Nexus Showcase, the centerpiece of the event. The selected group spans every stage of development, from pre-seed and early concept companies to post–Series A ventures, and reflects a wide range of technologies shaping the future of urologic care.Formerly known as the Innovation Nexus Conference, the reimagined Forum serves as the foundation of the AUA’s broader Innovation Nexus Ecosystem, an initiative focused on accelerating innovation in urology. The Forum is designed to bring together startups, clinicians, investors, and industry leaders in a highly interactive setting that emphasizes meaningful dialogue, collaboration, and real-world impact.TOBY’s participation underscores growing interest in new, non-invasive approaches to disease detection and risk assessment within urology. At the Forum, TOBY will join fellow innovators in sharing its work as part of the Innovation Nexus Showcase and engaging with leaders across the urologic ecosystem.More information about the 2026 AUA Innovation Nexus Forum and the selected innovators is available via the <a data-mce-href="https://www.auanet.org/about-us/media-center/press-center/aua-selects-43-innovators-for-2026-innovation-nexus-forum" href="https://www.auanet.org/about-us/media-center/press-center/aua-selects-43-innovators-for-2026-innovation-nexus-forum" title="AUA press release on 2026 Innovation Nexus Forum selections" target="_blank" rel="noopener">AUA announcement</a>. To learn more, visit <a data-mce-href="https://www.toby.health/" href="https://www.toby.health/" title="Visit Toby’s homepage">Toby.health</a>.<h3>About TOBY, Inc.:</h3>TOBY, inspired by Sherlock Holmes's Bloodhound, is a BioTech startup focused on the early detection of cancer utilizing mass spectrometry 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 mass spectrometry, 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 Selected to Present at AUA 2026 Innovation Nexus Forum

BOSTON, Sept. 2, 2025 /<a data-mce-href="https://www.prnewswire.com/news-releases/toby-appoints-healthcare-leader-matthew-collier-as-independent-director-302543833.html" href="https://www.prnewswire.com/news-releases/toby-appoints-healthcare-leader-matthew-collier-as-independent-director-302543833.html" title="View official press release on PR Newswire" target="_blank" rel="noopener">PRNewswire</a>/ -- TOBY, Inc., a leader in noninvasive multi-cancer early detections, has appointed Matthew Collier to the TOBY Board of Directors as an independent director. "Matthew Collier's strategic experience and vision for healthcare innovation will be an invaluable asset to TOBY as we accelerate our path to market," said Matthew Laskowski, CEO of TOBY. "His leadership across digital health and commercial strategy will help guide our mission to transform cancer screening worldwide." Collier brings over three decades of leadership in digital health, strategy, and life sciences. He currently serves as President and Chief Commercial Officer of Otonoma, where he is spearheading the commercialization of the world's first secure distributed intelligence network in partnership with Accenture and Nvidia. "I've spent my career at the intersection of healthcare, technology, and transformation, and I believe TOBY represents the next wave of innovation in early cancer detection," said Collier. "The opportunity to bring noninvasive, accessible testing to millions of people is not only disruptive, but also profoundly important in our fight against cancer. I look forward to supporting the team as they scale this breakthrough approach." As an independent director, Collier will provide objective oversight and strategic guidance as TOBY advances its groundbreaking technology toward commercialization. He joins a board that includes accomplished leaders in science, technology, and healthcare: TOBY Board of Directors: <ul><li>Matthew Laskowski, CEO, TOBY, Inc.</li><li>Dragan Sebisanovic, CSO, TOBY, Inc.</li><li>John Leggett, Director, Osterbury Capital LLC</li><li>Joseph Hanssen, Director, Osterbury Capital LLC</li><li>Matthew Collier, Independent Director</li></ul>Throughout his career, Collier has raised more than $500 million in private equity and venture capital and previously served as CEO of Sutherland Healthcare Solutions, where he led a successful turnaround resulting in double-digit growth through AI-enabled digital platforms. He has also held senior positions at Accenture, Bain &amp; Company, Satiety, Inc., Avocet Medical, McKinsey &amp; Company and has worked extensively in North America, Europe, China, and Asia Pacific. Collier holds an MBA from Northwestern University's Kellogg School of Management and a BS in Mechanical Engineering from Stanford University. To learn more, visit <a data-mce-href="https://www.toby.health/" href="https://www.toby.health/" title="Visit Toby’s homepage">Toby.health</a>. <h3>About TOBY, Inc.:</h3>TOBY, inspired by Sherlock Holmes's Bloodhound, is a BioTech startup focused on the early detection of cancer utilizing mass spectrometry 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 mass spectrometry, changes in biomarkers (VOCs), and cutting-edge computational algorithms to deliver early, easy, and affordable cancer screening.SOURCE TOBY, Inc.Media Contact: <a href="mailto:Press@Toby.health" data-mce-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 Appoints Healthcare Leader Matthew Collier as Independent Director

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">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 mass spectrometry 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 mass spectrometry, 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

TOBY

TOBY is a diagnostics platform using VOC analysis, spectroscopy, and AI to deliver early, noninvasive disease detection. Our first application, TOBY Oncology, is developing a simple urine test for early cancer detection.

News

TOBY Receives FDA Breakthrough Device Designation for Its...

TOBY Receives FDA Breakthrough Device Designation for Its...

A Medicare Pathway for Multi-Cancer Early Detection

TOBY Selected to Present at AUA 2026 Innovation Nexus Forum

TOBY Appoints Healthcare Leader Matthew Collier as Indepe...

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