TOBY, Inc., a Boston-based biotech startup, announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its TOBY Test for Bladder Cancer, marking a significant milestone for non-invasive cancer detection technology. The designation validates the company's approach to early cancer screening through urine-based volatilomics combined with artificial intelligence.
Revolutionary Approach to Bladder Cancer Detection
The TOBY Test represents a paradigm shift from current bladder cancer surveillance methods by analyzing volatile organic compounds (VOCs) in a single urine sample. The technology employs gas chromatography-mass spectrometry coupled with proprietary AI algorithms to generate real-time cancer risk scores, offering a painless and low-cost alternative to invasive procedures.
"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."
Addressing Critical Unmet Medical Need
Bladder cancer presents significant clinical and economic challenges as the sixth most common cancer in the United States. Despite its prevalence, it remains one of the costliest cancers to manage due to high recurrence rates and the current reliance on invasive surveillance tools like cystoscopy. The TOBY Test addresses these limitations by providing a non-invasive screening option that could transform patient care and reduce healthcare costs.
FDA Breakthrough Device Program Benefits
The FDA's Breakthrough Devices Program provides TOBY with enhanced regulatory support, including more frequent interactions with the agency and prioritized submission review. This designation is reserved for technologies that demonstrate significant advantages over current standards of care, positioning TOBY's platform for accelerated development and potential market entry.
Expanding Multi-Cancer Detection Platform
Beyond bladder cancer, TOBY is preparing for multi-cancer clinical studies to validate its platform's broader applications. The company's technology is designed to detect more than ten different cancers from a single non-invasive urine sample, potentially covering over 60% of global cancer cases. These studies will focus on validating the platform's accuracy, generalizability, and clinical value while establishing the foundation for large-scale screening programs based on VOC biomarkers and AI.
"This milestone is a leap forward not only for TOBY but for the patients and clinicians we aim to serve," Laskowski noted. "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."
Founded in 2023 and named after Sherlock Holmes's trusted bloodhound, TOBY represents a new generation of cancer detection companies leveraging advanced analytics and non-invasive sampling methods. The company's mission centers on making early detection routine, accessible, and precise through innovative volatilomics technology combined with artificial intelligence.
