Rhythm Biosciences has taken another step towards commercialising its ColoSTAT blood-based colorectal cancer test, securing a multi-year manufacturing agreement with US-based Quansys Biosciences to supply reagent kits at commercial scale.
The agreement provides Rhythm with ISO13485-certified manufacturing capacity to support both the ColoSTAT Access Program and a broader commercial rollout, while reducing scale-up and quality system risks following 2 years of collaborative assay development between the groups.
Importantly, the deal includes minimum order volumes and a defined pricing framework, giving Rhythm greater visibility over supply and cost of goods as testing volumes increase.
CEO and managing director Dr David Atkins said the agreement represented a significant step in building the infrastructure needed to support ColoSTAT’s commercialisation.
"Securing Quansys as our commercial manufacturing partner represents a key operational milestone in ColoSTAT®'s commercialisation pathway. Their proven expertise in multiplex immunoassay manufacturing, combined with ISO13485-certified facilities, provides Rhythm with the quality-assured, scalable supply capacity necessary to support the ColoSTAT® Access Program and prepare for broader market entry. This agreement demonstrates continued progress in building the commercial infrastructure required for ColoSTAT® deployment."
Manufacturing capacity secured ahead of market entry
Under the agreement, Quansys will act as Rhythm’s contract manufacturing partner for ColoSTAT consumable reagent kits, providing commercial-scale production from its ISO13485-certified facilities.
The partnership delivers flexible manufacturing capacity designed to scale in line with demand, supported by established quality management systems and global logistics infrastructure.
Rhythm said the agreement is funded from existing budgets and resources and includes standard termination and intellectual property provisions.
The manufacturing deal formalises a relationship that has spanned more than two years, during which the companies worked together on assay development, prototyping and analytical validation, evaluating thousands of test data points.
The shift from development to commercial manufacturing marks a key operational milestone in ColoSTAT’s pathway to market, as the company moves beyond validation and into execution.
Lower risk profile and cost visibility
From a commercial perspective, the agreement addresses a critical requirement for ColoSTAT’s deployment by ensuring a reliable, quality-assured supply of consumables required for test delivery.
Rhythm said the fixed pricing for the initial two-year term provides cost-of-goods predictability, while the use of an experienced, certified manufacturer reduces operational and execution risk ahead of wider market entry.
Quansys CEO Adam Brown said the partnership aligned with the company’s focus on high-quality multiplex immunoassays and supporting diagnostic innovation.
"We are excited to partner with Rhythm Biosciences on ColoSTAT®. Quansys has built its reputation on high-quality multiplex immunoassays, backed by strong manufacturing and quality systems. The opportunity to support a transformative colorectal cancer test aligns perfectly with our mission to empower researchers and clinicians in advancing diagnosis and treatment.”
Next steps
Rhythm will continue progressing the ColoSTAT Access Program while advancing regulatory and commercial partnership discussions, with further updates to be provided as material developments occur.