• ColoSTAT kit transitioned to final production validation stage
• ColoSTAT diagnostic performance consistent across colorectal cancer stages I to IV
• Performance meets clinical requirements for symptomatic patient testing use case

Rhythm Biosciences Ltd (ASX:RHY), a transformative, predictive cancer diagnostics technology company, is pleased to announce the results of an important study on the diagnostic assay performance of its ColoSTAT kits across different cancer stages. Following the completion of the ColoSTAT Beta kit verification and validation, the company has recently received a batch of ColoSTAT kits produced using the final manufacturing process. As part of the process validation, a set of new blood samples from patients with no neoplastic disease or stage I to IV cancers were evaluated to establish the effectiveness of ColoSTAT across the continuum of neoplastic bowel disease. The data on 300 patient samples shows that ColoSTAT is equally effective at detecting colorectal cancer across all stages (I to IV). Establishing ColoSTAT's performance across the entire range of neoplastic conditions is an important requirement for a clinically useful product. The company looks forward to reporting the results of the final validation of the kits, algorithm and instrumentation in the near term, ahead of a submission to NATA to add ColoSTAT to Rhythm's ISO15189 laboratory test portfolio. This will be followed by the commercial launch of ColoSTAT later in CY2025, subject to NATA regulatory approval timeline.