The multi-cancer early detection (MCED) space has been dominated by blood. Grail, Freenome, Exact Sciences, Guardant. Everybody’s chasing the same idea: find cancer signals in a blood draw before symptoms appear.
TOBY, Inc. is chasing the same idea with a different sample. Urine.
The Boston-based company received FDA Breakthrough Device Designation for its urine-based MCED test, which detects cancer-associated molecular signatures from a single urine sample across multiple tumor types.
The platform works by analyzing volatile organic compounds (VOCs), the gaseous metabolites that cancer cells shed, using spectroscopy and machine learning to identify cancer-specific patterns.
Breakthrough Device Designation is the FDA’s way of fast-tracking development for technologies that address unmet needs. It gives TOBY more direct FDA engagement, priority review potential, and a clearer regulatory pathway. For a diagnostic company, that regulatory access can shave years off the timeline to market.
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The appeal of urine over blood for population-scale screening is obvious.
No needle.
No phlebotomist.
No clinical visit required.
You could theoretically send a collection kit to someone’s house and have them mail it back. That changes the compliance calculus for screening programs entirely, especially for the populations that avoid blood draws or don’t have easy access to clinical labs.
The science of VOC profiling for cancer detection isn’t new. Researchers have been studying it for over a decade, and there’s a reasonable body of literature showing cancer-specific VOC signatures across multiple tumor types.
What’s new is pairing that with modern ML to build a clinically validated, multi-cancer test rather than a single-analyte assay.
Details are thin. TOBY hasn’t disclosed specific cancer types covered, sensitivity or specificity data, clinical trial enrollment, or funding.
It’s early. But the FDA doesn’t hand out Breakthrough Device Designations to companies without credible preliminary evidence.
For a space that’s been defined by liquid biopsy blood tests, this is a genuinely different approach worth watching. If the performance data holds up against the blood-based players, the collection advantage alone could make this competitive at scale.
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