ColoSTAT® Beta Kit Nears Market Amid Critical Clinical Testing Phase

A Milestone in Colorectal Cancer Diagnostics

Rhythm Biosciences Ltd (ASX: RHY), an Australian medical diagnostics innovator, has announced a significant advancement in its flagship product, the ColoSTAT® Beta assay kit. This second-generation blood-based test for colorectal cancer detection has successfully completed rigorous verification and validation processes, confirming it meets the stringent performance criteria required for commercial application.

Colorectal cancer remains a leading cause of cancer mortality worldwide, and early detection is critical for improving patient outcomes. Rhythm’s ColoSTAT® test measures five protein biomarkers to assess cancer risk, offering a simpler alternative for individuals reluctant or unable to participate in conventional screening programs.

Enhanced Performance and Efficiency

The Beta kit builds on the foundation laid by the earlier Alpha version, delivering substantial improvements in assay precision, reliability, and robustness. Rhythm and its development partner Quansys generated approximately 23,000 data points during verification testing, with over 96% of tests meeting or exceeding performance targets. The remaining minor discrepancies are expected to be addressed in the final manufactured product.

Key enhancements include a multiplex assay format that simplifies routine laboratory workflows, reduces hands-on time, and shortens turnaround times. These improvements are critical for scaling the test’s use in clinical settings, where efficiency and reliability are paramount.

Path to Commercialisation

With validation complete, Rhythm is transitioning the Beta assay to the final manufacturing phase with Quansys, aiming to produce pilot kits for further clinical testing. This next step involves independent evaluation using new clinical samples to confirm the assay’s performance before commercial launch.

Dr David Atkins, Rhythm’s CEO, highlighted the significance of this milestone: "This is the first time the Company has had a truly stable and reliable, simple to use ColoSTAT® assay with the necessary consistency of demonstrated performance. We are excited to confidently advance to our final testing phase, with commercialisation activities being able to be planned."

Rhythm’s progress underscores its commitment to delivering accessible, affordable diagnostics that can reduce the global burden of colorectal cancer. The company’s ongoing collaboration with global partners and adherence to regulatory standards positions ColoSTAT® as a promising tool in cancer detection.