Rhythm Biosciences Launches ColoSTAT® Commercialisation, Secures NHS England Partnership

A Milestone Quarter for Rhythm Biosciences

Rhythm Biosciences Ltd (ASX, RHY) has marked a pivotal moment in its evolution from a development-stage biotech to a commercial enterprise. The company announced the commencement of commercialisation for ColoSTAT®, its blood-based test designed to detect colorectal cancer early, after securing ISO 15189, 2022 accreditation. This accreditation is a critical regulatory milestone, confirming ColoSTAT®’s readiness for clinical use in Australia.

ColoSTAT® aims to address a significant healthcare challenge, annually, over 800,000 Australians undergo colonoscopies for symptoms suggestive of colorectal cancer, yet fewer than 5% are diagnosed with cancer. By helping clinicians triage patients more effectively, ColoSTAT® can reduce unnecessary invasive procedures, alleviate patient anxiety, and ease the burden on healthcare resources.

Global Validation Through NHS England Partnership

Adding to its commercial momentum, Rhythm secured a partnership with NHS England, one of the world’s most respected healthcare systems, to independently evaluate ColoSTAT®. This endorsement not only validates the science underpinning the test but also opens doors for international expansion, particularly across Europe. The NHS evaluation is a significant vote of confidence, positioning ColoSTAT® as a competitive player on the global stage.

Expanding the geneType™ Platform

Alongside ColoSTAT®, Rhythm’s geneType™ platform, which offers genetic risk assessments for multiple cancers, continues to gain traction. The company announced new partnerships in the United States, including with CatchBio and CancerIQ, targeting the world’s largest healthcare market. Notably, Rhythm delivered an enhanced colorectal cancer risk assessment test ahead of schedule, improving accuracy across genders and expanding its addressable market.

Scientific credibility for geneType™ was further bolstered by a peer-reviewed validation published by Harvard Medical School, confirming the ovarian cancer risk model’s ability to identify twice as many at-risk women compared to clinical models alone. This independent validation strengthens Rhythm’s position in precision medicine and preventative healthcare.

Financial and Leadership Strength

Rhythm’s financial position improved during the quarter with the receipt of a $1.571 million Research and Development tax incentive refund, enabling the full repayment of a $1 million loan. Cash and cash equivalents stood at $1.643 million, providing an estimated 5.4 quarters of funding runway. Leadership transition was completed with the appointment of Gavin Fox-Smith as Chair, bringing fresh expertise to guide the company through its commercial phase.

Despite some delays in geneType™ sales due to contract finalisations, Rhythm is optimistic about growth prospects in the coming quarters. The company’s focus remains on expanding commercial traction, deepening strategic partnerships, and progressing supply arrangements for ColoSTAT®.

Looking Ahead

As Rhythm Biosciences moves into the next quarter, the emphasis will be on leveraging its accreditation and partnerships to drive revenue growth and broaden market reach. The NHS England evaluation results and the expansion of geneType™ partnerships will be key indicators of the company’s trajectory. With a strengthened balance sheet and a clear commercial strategy, Rhythm is poised to transform early cancer detection and risk assessment on both domestic and international fronts.