TOBY urine multi-cancer early detection test

Overview

1. 14 Apr 2026DesignationUS

   FDA Breakthrough Device designation for TOBY's urine-based multi-cancer early detection test (company announcement, as reported) source

• 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).