FDA Fast-Tracks AI 'Bloodhound' That Sniffs Out Cancer in Urine

The FDA has granted Breakthrough Device Designation to TOBY's revolutionary bladder cancer test.
The technology uses AI to analyze chemical signatures in a single urine sample, replacing the need for invasive cystoscopies.
This milestone accelerates the path to making early, painless, and affordable cancer screening accessible to all.

For countless patients, bladder cancer surveillance means a recurring, invasive ordeal: the cystoscopy. Now, that painful reality is on the verge of a revolutionary change. Biotech innovator TOBY, Inc. has just received a major boost from the U.S. Food and Drug Administration (FDA), which granted Breakthrough Device Designation to its pioneering AI-powered urine test^{1, 2, 3, 4, 5}.

Named after Sherlock Holmes’s trusted bloodhound, the TOBY Test is designed to "sniff out" cancer's chemical clues. It analyzes volatile organic compounds (VOCs) in a single, painless urine sample, using sophisticated AI to generate a real-time cancer risk score. This one-step process stands to replace the discomfort and high costs associated with current diagnostic methods, which require a camera to be inserted through the urethra^{1, 4, 5}.

"This milestone is a leap forward not only for TOBY but for the patients and clinicians we aim to serve," said CEO Matthew Laskowski. The FDA's designation validates the test's immense potential and will fast-track its development, bringing it closer to the clinic^{2, 4, 5}. With plans to expand its platform to detect over ten different cancers, TOBY is on a mission to make early detection as simple as a routine check-up^{5, 6, 7}.

FDA Fast-Tracks AI 'Bloodhound' That Sniffs Out Cancer in Urine

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