FDA Grants Breakthrough Status to AI-Enhanced GC-MS Device for Bladder Cancer Detection

The United States Food and Drug Administration (FDA) has granted TOBY, a biotechnology startup focused on non-invasive cancer detection, Breakthrough Device Designation status for its bladder cancer test. The test uses gas chromatography–mass spectrometry (GC–MS) and proprietary AI, to analyze volatile organic compounds (VOCs) in a single urine sample to generate a real-time cancer risk score. Urine analysis is known for its non-invasive nature, availability in large volumes, and the high concentration of VOCs that can be found in the kidneys (3).

"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,” said Matthew Laskowski, chief executive officer of TOBY said in a June 30 press release (1).

Bladder cancer is the sixth most common cancer in the U.S. and is also the 10^th leading cause of death (1,2). According to the American Cancer Society, there have been approximately 84870 new cases of bladder cancer in 2025, with approximately 17420 deaths from bladder cancer. Despite its prevalence, bladder cancer remains extremely costly to manage due to its high recurrence and reliance on invasive surveillance tools, such as cystoscopy. This has led to research on more patient-friendly means of detection.

According to TOBY, their test received an “excellent” rating in detecting bladder cancer by demonstrating an area under the curve greater than 0.9 in internal validation assessments (4). This is based on measurements of AUC, or “Area Under the Curve” (5). This statistic measures how accurately a test can distinguish between positive and negative cases, such as cancer and no cancer. These values can range from 0.5 to 1.0, the former meaning a test is no better than random chance and the latter indicating a perfect test. The diagnostics test view performances below 0.8 as poor performances, with above 0.9 as excellent. The test was also rated as excellent across all other cancer types including prostate and kidney cancer.

The FDA’s Breakthrough Devices Program is a voluntary program for certain medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions (6). The program is meant to provide patients and healthcare providers with timely access to medical devices through speeding up development, assessment, and review for premarket approval, 510(k) clearance, and de novo marketing authorization. The devices in the Breakthrough Devices Program face rigorous standards for device safety and effectiveness to be authorized for marketing.

TOBY was founded in 2023, using volatilomics and AI to develop new means of urine-based cancer screening. Its platform is meant to detect more than ten cancers from a single non-invasive sample, representing more than 60%of global cancer cases. The company touts its goal as making early cancer detection routine, accessible, and precise.

"We founded TOBY to uncover what conventional methods often miss,” Laskowski said. “With FDA's support, we're one step closer to making early cancer detection effortless and accessible for everyone."

References

(1) TOBY, Inc. FDA Grants Breakthrough Device Designation to TOBY's AI-Powered Urine Test for Early Bladder Cancer Detection. PR Newswire 2025.https://www.prnewswire.com/news-releases/fda-grants-breakthrough-device-designation-to-tobys-ai-powered-urine-test-for-early-bladder-cancer-detection-302493602.html (accessed 2025-7-1)

(2) Key Statistics for Bladder Cancer. American Cancer Society 2025. https://www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html (accessed 2025-7-1)

(3) Da Costa, B. R. B.; De Martinis, B. S. Analysis of Urinary VOCs Using Mass Spectrometric Methods to Diagnose Cancer: A Review. Clin. Mass Spectrom. 2020, 18, 27–37. DOI: 10.1016/j.clinms.2020.10.004

(4) Clarke, H. FDA Grants Breakthrough Device Designation to Urine Test for Bladder Cancer Detection. Urology Times 2025. https://www.urologytimes.com/view/fda-grants-breakthrough-device-designation-to-urine-test-for-bladder-cancer-detection (accessed 2025-7-1)

(5) Our Roadmap. TOBY 2025. https://www.toby.health/product (accessed 2025-7-1)

(6) Breakthrough Devices Program. FDA 2025. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program (accessed 2025-7-1)