How Rhythm Biosciences Validated ColoSTAT® and Secured Its First Genetype Partnership

Strong Validation and Commercial Readiness for ColoSTAT®

Rhythm Biosciences has marked a significant milestone with the successful clinical validation of its ColoSTAT® blood test for colorectal cancer detection. The proprietary diagnostic algorithm demonstrated an 89% sensitivity and 99% negative predictive value across 200 independent clinical samples, meeting the defined clinical benchmarks for both symptomatic and patient populations. This validation confirms ColoSTAT®’s potential as a reliable, non-invasive alternative to traditional screening methods, particularly for individuals reluctant or unable to participate in existing programs.

Following this, the test has progressed into its final production validation phase, a critical step before commercial launch. Rhythm’s collaboration with manufacturing partner Quansys Biosciences has yielded pilot production kits, and the company is advancing ColoSTAT® towards NATA accreditation as an in-house in vitro diagnostic service, enhancing its regulatory and commercial positioning.

Genetype Integration and Commercial Expansion

The integration of Genetype, acquired in December 2024, has been completed ahead of schedule, expanding Rhythm’s product portfolio into genetic risk assessment. Genetype’s platform combines polygenic risk scores with clinical data to provide personalized risk insights across multiple cancers and diseases. The company announced its first strategic partnership under an initial pilot program, signaling market confidence and commercial validation of the Genetype portfolio.

Additionally, Genetype has reinstated its personal NATA accreditation, reaffirming its clinical credibility. The commercial pipeline continues to grow, supported by scalable and compliant operational infrastructure. A collaboration with the University of Melbourne is progressing well, having already utilized over 25% of the contracted study volume, further underpinning the commercial momentum.

Financial Position and Funding Support

Rhythm Biosciences reported FY25 revenue performance aligned with acquisition model assumptions, validating the strategic rationale behind the Genetype acquisition. The company secured $1 million in non-dilutive funding through an R&D Tax Incentive (RDTI) loan facility, providing working capital to support ongoing growth initiatives. Despite operating cash outflows, Rhythm maintains confidence in its ability to continue operations and execute its growth strategy, supported by a proven track record of capital raising and a diversified product portfolio.

Leadership Transition and Shareholder Benefits

The company announced a planned board leadership transition, with Non-Executive Chairman Otto Buttula set to retire at the 2025 AGM. Gavin Fox-Smith, a Non-Executive Director with extensive health technology experience, will assume the Chairman role. This change is positioned as a strategic evolution to drive continued execution and value creation.

Rhythm also introduced shareholder discount programs for its geneType™ multi-risk genetic test and plans a similar offer for the upcoming ColoSTAT® test, aiming to engage shareholders directly with its innovative diagnostic solutions.

Looking Ahead

With ColoSTAT® nearing commercial launch and Genetype’s portfolio expanding through strategic partnerships and clinical collaborations, Rhythm Biosciences is poised for a transformative FY26. The company’s integrated proteomic and genomic platforms position it well to capitalize on growing demand for early cancer detection and personalized health risk assessments.