Rhythm’s ColoSTAT® Launch Hinges on NATA Accreditation Reinstatement
Rhythm Biosciences has regained NATA accreditation for its geneType laboratory, a key step toward commercialising its ColoSTAT® cancer risk test as an in-house diagnostic.
- NATA accreditation reinstated for geneType laboratory
- Integration of Genetype assets completed post-acquisition
- Enables ColoSTAT® deployment as an in-house in vitro diagnostic
- Supports clinical rollout and real-world data collection
- Advances Rhythm’s global commercialisation strategy
Accreditation Milestone Achieved
Rhythm Biosciences Ltd (ASX, RHY) announced on 24 June 2025 that it has successfully reinstated the National Association of Testing Authorities (NATA) accreditation for its geneType laboratory operations. This accreditation had been temporarily suspended following Rhythm’s acquisition of Genetype assets earlier this year. The reinstatement marks the completion of the laboratory integration process and restores Rhythm’s ability to provide accredited genetic risk assessment testing services.
Strategic Importance for ColoSTAT®
The reacquisition of NATA accreditation is more than a regulatory checkbox; it is a critical enabler for Rhythm’s flagship ColoSTAT® assay. ColoSTAT® is a blood-based test designed to assess colorectal cancer risk by measuring specific protein biomarkers. With the laboratory now fully accredited under Rhythm’s ownership, the company is positioned to progress ColoSTAT® as an in-house in vitro diagnostic (IVD) within Australia. This status will allow clinical deployment and the collection of real-world performance data, essential for regulatory approvals and broader commercialisation.
Broader Implications for Cancer Diagnostics
Colorectal cancer remains a leading cause of cancer mortality worldwide, and early detection is key to improving outcomes. Rhythm’s ColoSTAT® test offers a simpler, less invasive alternative to traditional screening methods, potentially increasing screening uptake among those reluctant or unable to participate in existing programs. The reinstatement of NATA accreditation for the geneType platform, which supports multiple disease risk assessments, further strengthens Rhythm’s position in the preventative healthcare and precision medicine markets.
Looking Ahead
CEO Dr. David Atkins highlighted the significance of this milestone, noting it as a stepping stone toward scaling clinical availability and commercial launch. While the announcement does not specify exact timelines for the variation assessment to add ColoSTAT® as an accredited service, the company’s progress signals a clear path toward domestic market entry and eventual global commercialisation. Investors and industry watchers will be keen to monitor subsequent regulatory filings and clinical deployment updates.
Bottom Line?
With NATA accreditation reinstated, Rhythm Biosciences is set to accelerate ColoSTAT®’s clinical rollout and commercial journey.
Questions in the middle?
- When will Rhythm complete the variation assessment to add ColoSTAT® as an accredited service?
- What are the expected timelines for ColoSTAT®’s commercial launch in Australia and beyond?
- How will Rhythm leverage the geneType platform’s multi-disease capabilities to expand its market footprint?
