NATA Accreditation Awarded for Genetype Laboratory

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Stock RHYTHM Biosciences Ltd (RHY.ASX)
Release Time 24 Jun 2025, 9:16 a.m.
Price Sensitive Yes
 NATA Accreditation Awarded for Genetype Laboratory
Key Points
  • Reinstatement of NATA accreditation for the Genetype risk assessment portfolio
  • A key milestone for securing ColoSTAT® accreditation and commercial launch as an in house IVD
Full Summary

Rhythm Biosciences Ltd (ASX:RHY), a transformative, predictive cancer diagnostics technology company, has attained NATA accreditation for the geneType cancer risk assessment assay portfolio. Following the transfer of the Genetype assets to Rhythm during the asset acquisition from Genetic Technologies Ltd earlier in 2025, the previously held Genetype NATA accreditation was temporarily suspended. Rhythm has now secured full reinstatement of this accreditation, which completes the laboratory integration. This milestone marks the successful conclusion of the integration of the Genetype laboratory under Rhythm's ownership and ensures continuity of accredited testing services moving forward. Importantly, this reinstatement is also crucial for advancing the Company's ColoSTAT® commercialization strategy. With an ISO 15189-accredited quality system now under Rhythm's control, the company is positioned to progress ColoSTAT® as an in-house IVD subject to the completion of a variation assessment to add ColoSTAT® as a Rhythm accredited service. This will allow the Company to deploy ColoSTAT® in a clinical setting and generate real-world performance data, an essential step in the objective to ultimately commercialize ColoSTAT® globally as a regulated in vitro diagnostic.

Outlook

Reinstating NATA accreditation for Genetype is an important enabler for Rhythm's plans to scale the clinical availability of this important portfolio of cancer risk assessment assays. Furthermore, this is a significant stepping stone to allow the company to offer ColoSTAT® as an in-house IVD for the domestic market in the coming months.