• Rhythm completed final validation of ColoSTAT kit, algorithm, and instrumentation
• ColoSTAT demonstrated 91% sensitivity for colorectal cancer detection in high-risk individuals
• High negative predictive value of 98% supports ColoSTAT as a safe triage tool

Rhythm Biosciences Ltd has announced the completion of the final full system validation of its ColoSTAT colorectal cancer detection test. The validation process involved extensive testing using a range of clinical samples, and the results demonstrate that ColoSTAT's performance will meet the needs for its intended initial clinical indication. Specifically, the validation data shows that ColoSTAT achieved a sensitivity of 91% for the identification of colorectal cancer in individuals considered at higher risk (over 45 years of age). Additionally, the test has a high Negative Predictive Value of 98%, indicating that it has the performance characteristics required to be used as a safe triage tool for patients with symptoms of bowel cancer. This could provide an effective alternative for symptomatic individuals who prefer not to undergo stool-based testing before deciding on the use of colonoscopy. Rhythm has now submitted the laboratory validation data to the National Association of Testing Authorities (NATA) in order to add ColoSTAT to the company's existing ISO15189 test portfolio, a critical step towards the commercialization of the test. The company remains committed to driving ColoSTAT towards regulatory approval and commercial roll-out, with further updates to be provided as progress is made.

Rhythm Biosciences is focused on bringing the ColoSTAT colorectal cancer detection test to market. The company is working to secure regulatory approval and establish commercial pathways for the test. Rhythm also plans to continue building its evidence base through clinical partnerships to further demonstrate the performance and utility of ColoSTAT.