# TOBY urine multi-cancer early detection test

Source: https://onco.cc/drugs/toby-urine-mced/  
OnCo record `toby-urine-mced` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A urine test in development from TOBY, Inc. that looks for cancer-linked chemicals in urine; it received FDA Breakthrough Device designation in April 2026, and its only performance figures are the company's own.

## Summary

TOBY, Inc. announced on 14 April 2026, in a release datelined Austin, Texas, that the FDA had granted Breakthrough Device designation to its urine-based multi-cancer early detection test, following an earlier designation for its urine bladder cancer test in June 2025. As reported from the release (Urology Times, 14 April 2026), the company says its internal validation gave an area under the curve above 0.9 for prostate, bladder and kidney cancer, and that the platform is intended to detect more than 10 cancers; no cohort size, sensitivity or specificity was given. No peer-reviewed paper, registered trial, launch date or price was found on 3 November 2026.

## Fields

- Kind: Test
- Status: emerging
- Last checked: 2026-11-03
- Tags: test; mced; evidence:insufficient
- Brand: TOBY
- Modality: Multi-cancer early detection urine test in development (volatile organic compounds, spectroscopy)
- Mechanism: Reads volatile organic compounds in a urine sample by spectroscopy and uses machine learning to recognise patterns associated with cancer.

## Notes

- Evidence grade insufficient for the claim that taking this test reduces late-stage diagnosis or cancer deaths: no randomised trial of it has reported either outcome, and its published performance comes from case-control or single-arm studies. The only randomised result for any multi-cancer test, NHS-Galleri, did not show fewer stage III or IV cancers.
- The only performance figures are the company's internal ones, without a cohort.
- What a result means: a positive result is a reason for further tests, not a diagnosis; a negative result does not rule cancer out and does not replace the screening tests that have been shown to work (bowel, breast, cervical and, where eligible, lung screening).

## Sources

- Urology Times: FDA Breakthrough designation for TOBY's urine test (14 April 2026): https://www.urologytimes.com/view/fda-grants-breakthrough-device-designation-to-urine-based-multi-cancer-early-detection-test

## Connected records

- drugs: [Elypta GAGome multi-cancer test](https://onco.cc/drugs/gagome-mced-test/), [N-NOSE](https://onco.cc/drugs/n-nose/)
- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Prostate cancer](https://onco.cc/cancers/prostate/), [Renal cell carcinoma](https://onco.cc/cancers/rcc/)
- technologies: [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [Multi-cancer early detection (MCED)](https://onco.cc/technologies/mced/)

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