Rhythm Biosciences Signs Manufacturing Agreement

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Stock RHYTHM Biosciences Ltd (RHY.ASX)
Release Time 3 Feb 2026, 8:45 a.m.
Price Sensitive Yes
 Rhythm Biosciences Signs Manufacturing Agreement for ColoSTAT®
Key Points
  • Multi-year commercial supply agreement with Quansys Biosciences for ColoSTAT® reagent kit manufacturing
  • Quansys operates ISO13485-certified facilities with established quality systems
  • Agreement reduces manufacturing scale-up and quality system risk
Full Summary

Rhythm Biosciences Ltd (ASX: RHY), a transformative, predictive cancer diagnostics technology company, has announced the execution of a strategic supply agreement with Quansys Biosciences, a US-based specialist manufacturer of multiplex immunoassay products. Under the agreement, Quansys Biosciences will serve as the contract manufacturing partner for ColoSTAT® consumable reagent kits, providing commercial-scale manufacturing capacity, ISO13485-certified production facilities with established quality management systems, a multi-year supply commitment supporting the ColoSTAT® Access Program and subsequent commercial launch, flexible manufacturing capacity to scale with market demand, and established logistics and distribution infrastructure for global supply. The agreement formalises a collaboration that has spanned two years of assay development, prototyping, and analytical validation activities, including evaluation of thousands of test data points. This transition to commercial manufacturing represents a significant operational milestone in ColoSTAT®'s path to market. The manufacturing agreement addresses critical requirements for ColoSTAT®'s commercialisation by providing reliable, quality-assured supply of consumable kits, enabling the Company to support anticipated testing volumes under the ColoSTAT® Access Program, establishing scalable infrastructure ahead of broader commercial deployment, and reducing operational risk through partnership with an experienced, certified manufacturer.