FDA Grants Breakthrough Designation for Novel Bladder Cancer Diagnostic
The FDA designates the TOBY Test as a breakthrough device, revolutionizing bladder cancer detection with a non-invasive, AI-driven urine test.
US FDA
- The FDA has granted breakthrough device designation to the TOBY Test for bladder cancer.
- The TOBY Test is a urine-based test using artificial intelligence (AI) algorithms.
- This represents an easier and more accessible option for bladder cancer detection and monitoring compared with standard cystoscopy.
The TOBY Test has received breakthrough device designation from the FDA for the early detection of bladder cancer. This designation underscores the significant potential of this innovative urine-based assay to fundamentally alter the landscape of bladder cancer detection and surveillance, offering a much-needed non-invasive alternative to current diagnostic paradigms.
The TOBY Test represents a sophisticated advancement in cancer diagnostics, leveraging the power of urine-based volatilomics combined with AI algorithms. At its core, the technology analyzes volatile organic compounds present in a single urine sample using gas chromatography-mass spectrometry. Proprietary AI then processes these intricate chemical signatures to generate a real-time cancer risk score, providing clinicians with a novel tool for assessment. This one-step, painless procedure contrasts sharply with the invasive and often uncomfortable methodologies that currently dominate bladder cancer management.
Bladder cancer, while the sixth most common cancer in the US, poses unique challenges in its clinical management, primarily due to its high recurrence rate and the subsequent necessity for frequent, invasive surveillance. Cystoscopy, the current gold standard for diagnosis and monitoring, involves the insertion of a rigid or flexible tube with a camera into the bladder, a procedure that, while effective, can be distressing for patients and contributes significantly to the overall cost burden of the disease. The reliance on such invasive tools for ongoing surveillance translates into substantial healthcare expenditures and patient discomfort, highlighting a critical unmet need for more accessible and less burdensome diagnostic options.
Bladder cancer, light micrograph, photo under microscope: ©Dr_Microbe - stock.adobe.com
The FDA's breakthrough devices program is specifically designed to expedite the development and review of medical devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. For the TOBY Test, this designation signifies that the FDA recognizes its potential to provide a substantial clinical advantage over existing standards of care. As a result, TOBY Inc. will benefit from more frequent and intensive interactions with the FDA throughout the device's development and premarket review phases, potentially accelerating its path to market availability.
Matthew Laskowski, chief executive officer of TOBY Inc., emphasized the importance of this regulatory milestone in a press release. "This designation validates the potential of our one-step urine test to detect bladder cancer at its most treatable stage," Laskowski said. He further noted that this enhanced collaboration with the FDA presents "a unique opportunity to work more closely with the FDA, accelerate our clinical development, and make early, accessible, and affordable cancer screening a reality."
