Rhythm Biosciences (ASX: RHY) has executed a strategic supply agreement with US-based Quansys Biosciences, securing commercial-scale production of its ColoSTAT® reagent kits. The multi-year supply commitment formalises two years of successful assay development collaboration and provides scalable manufacturing capacity to support the ColoSTAT® Access Program and subsequent commercial rollout.
What the Quansys Agreement Delivers
The agreement addresses critical commercialisation infrastructure by locking in certified manufacturing capacity with quality assurance provisions. Quansys Biosciences operates ISO13485-certified production facilities with established quality management systems, providing the regulatory compliance framework necessary for diagnostic test manufacturing.
The agreement includes flexible manufacturing capacity designed to scale with market demand, alongside established logistics and distribution infrastructure for global supply. Pricing is fixed for an initial two years, providing cost predictability for the company’s commercial rollout planning. The partnership is funded from existing budgets and resources, requiring no additional capital raise.
| Provision | Detail | Benefit | Status |
|---|---|---|---|
| Manufacturing Partner | Quansys Biosciences | Specialist multiplex expertise | Confirmed |
| Certification | ISO13485 | Quality-assured production | Active |
| Term | Multi-year | Supply security | Locked in |
| Pricing | Fixed for 2 years | Cost predictability | Confirmed |
The agreement includes provisions for minimum order volumes and a pricing framework designed to support anticipated operational requirements as the ColoSTAT® test transitions from access programme to commercial deployment.
Understanding Contract Manufacturing in Diagnostics
Diagnostics companies frequently outsource manufacturing to certified specialists rather than building internal production facilities. This approach delivers three key advantages:
-
Regulatory compliance infrastructure: ISO13485 certification demonstrates that manufacturing processes meet international quality management standards specific to medical devices. This certification is often a prerequisite for regulatory submissions and commercial partnerships in diagnostic markets.
-
Capital efficiency: Partnering with established manufacturers eliminates the need for significant capital investment in production facilities, quality systems, and ongoing compliance management. Companies can instead allocate resources to clinical validation, regulatory pathways, and market development.
-
Scalability and risk mitigation: Certified manufacturers provide proven production capacity that can flex with demand. This reduces the operational risk of supply constraints during commercial launch phases when testing volumes may increase rapidly.
For a blood-based cancer test entering clinical use through an access programme, securing quality-assured manufacturing capacity removes a material commercialisation hurdle. The partnership validates that production processes can deliver consistent, compliant test kits at the volumes required for broader clinical deployment.
Commercial Roadmap Implications
The manufacturing agreement enables Rhythm Biosciences to support anticipated testing volumes under the ColoSTAT® Access Program with reliable supply. The two-year development collaboration that preceded this commercial agreement involved assay development, prototyping, and analytical validation activities, including evaluation of thousands of test data points. This extended validation period de-risks the transition to commercial-scale production.
The partnership provides scalable infrastructure ahead of broader commercial deployment, positioning the company to respond to demand as the Access Program progresses and potential commercial partnerships advance. By securing manufacturing capacity now, Rhythm Biosciences addresses a critical operational requirement before it becomes a constraint on growth.
CEO Commentary
“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,” said Dr David Atkins, CEO and Managing Director.
Quansys Perspective
The manufacturing partnership represents strategic alignment between Quansys Biosciences’ capabilities and Rhythm’s commercialisation requirements. Quansys CEO Adam Brown noted the alignment with the company’s core mission.
“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,” Brown stated.
What Comes Next for Rhythm Biosciences
With manufacturing infrastructure secured, the company’s focus shifts to clinical validation and commercial partnership development. Three active workstreams are advancing in parallel:
-
ColoSTAT® Access Program: Ongoing clinical deployment generating real-world performance data
-
Regulatory discussions: Progressing towards formal regulatory submissions
-
Commercial partnership discussions: Advancing conversations with potential distribution and commercialisation partners
The manufacturing agreement positions Rhythm Biosciences to respond to demand generated by these parallel initiatives. As the Access Program generates clinical validation data and regulatory pathways advance, the secured production capacity eliminates supply chain constraints as a potential bottleneck.
For investors, the next material catalysts to monitor are updates on Access Program clinical data, regulatory submission progress, and potential commercial partnership announcements. The manufacturing agreement removes operational risk from the commercialisation pathway, allowing focus to shift to market validation and partnership execution.
Want the Next Healthcare Breakthrough in Your Inbox?
Join 20,000+ investors getting FREE breaking ASX healthcare news delivered within minutes of release, complete with in-depth analysis. Click the “Free Alerts” button at Big News Blast to receive market-moving announcements the moment they drop, with expert coverage already done.