Rhythm Biosciences partners with 4Cyte Pathology to expand ColoSTAT blood test access
Rhythm Biosciences (ASX: RHY) has entered into a Rhythm Biosciences 4Cyte ColoSTAT Partnership, securing access to over 1,000 patient collection centres across New South Wales, Victoria, and Queensland through a non-exclusive distribution agreement with 4Cyte Pathology. The three-year agreement requires no upfront payments or minimum volume commitments, creating a capital-efficient pathway to expand ColoSTAT’s commercial reach while complementing the company’s existing ColoSTAT Access Programme.
The partnership integrates ColoSTAT into 4Cyte’s clinical ordering systems, enabling healthcare practitioners to order the blood-based colorectal cancer screening test through the same pathology workflows they use daily. 4Cyte will facilitate patient sample collection through its phlebotomy network, with serum samples transported to Rhythm’s ISO 15189:2022-accredited laboratory in Parkville, Victoria for analysis. Results will be delivered to referring practitioners via 4Cyte’s established reporting systems, with Rhythm invoicing patients directly on a per-test basis.
The agreement positions ColoSTAT within an established clinical infrastructure across Australia’s eastern seaboard, addressing a key operational barrier to test adoption without requiring Rhythm to invest in duplicative collection networks.
How the 4Cyte partnership works
Under the Distribution Service Agreement, 4Cyte will integrate ColoSTAT into its clinical ordering platform across its network of over 1,000 collection centres spanning three states. Healthcare practitioners can order the test through existing pathology systems, with 4Cyte coordinating patient sample collection via its phlebotomy services.
Once collected, serum samples are transported to Rhythm’s Parkville laboratory using 4Cyte’s courier logistics. All ColoSTAT analysis is performed at Rhythm’s facility, which holds ISO 15189:2022 accreditation for medical testing. Results are then delivered back to the referring practitioner through 4Cyte’s reporting infrastructure.
4Cyte, founded in 2017, operates NATA-accredited laboratories and services a broad network of general practitioners, specialists, and medical centres across the Australian eastern seaboard. The company’s established presence provides immediate geographic coverage without requiring Rhythm to build parallel collection infrastructure.
| Term | Detail |
|---|---|
| Duration | 3 years initial + 2-year extension option |
| Exclusivity | Non-exclusive |
| Revenue model | Per-test, direct patient invoicing |
| Upfront cost | Nil |
| Minimum volumes | None |
Rhythm retains all intellectual property rights in ColoSTAT, while patient data handling will comply with applicable Australian privacy legislation. The non-exclusive structure allows Rhythm to appoint additional distributors or provide ColoSTAT services directly in all Australian jurisdictions.
Why blood-based colorectal cancer screening matters for investors
ColoSTAT measures five protein biomarkers in a blood sample to indicate the likelihood of colorectal cancer (CRC). The test is designed as an alternative screening pathway for individuals with symptoms of bowel cancer who are unable or unwilling to complete faecal-based screening methods such as the faecal immunochemical test (FIT).
Colorectal cancer is the second leading cause of cancer deaths globally. While early detection significantly improves treatment outcomes, colorectal cancer screening participation in Australia remains below 50%. This participation gap creates demand for alternative screening pathways that may be more acceptable to patients avoiding faecal-based tests.
ColoSTAT addresses this unmet need by offering:
- Blood-based collection through a simple phlebotomy procedure familiar to patients
- Targeted application for symptomatic individuals seeking screening alternatives
- Clinical pathway integration through existing practitioner workflows rather than standalone programmes
The sub-50% screening participation rate represents a significant addressable market for alternative screening technologies. By positioning ColoSTAT within established pathology networks, Rhythm aims to capture demand from patients who have not engaged with existing screening programmes.
Commercial benefits and capital-efficient growth strategy
The partnership delivers three key commercial advantages while maintaining a variable cost structure aligned with testing volumes:
- Geographic reach across 1,000+ collection centres spanning New South Wales, Victoria, and Queensland, providing substantial coverage of Australia’s east coast population
- Operational leverage of 4Cyte’s existing phlebotomy services and courier logistics for sample collection and transport, eliminating the need for Rhythm to invest in duplicative infrastructure
- Promotional capability through 4Cyte’s clinical engagement with general practitioners and specialists across its practitioner network
The agreement requires no upfront capital commitment and no minimum volume guarantees from either party. Revenue is generated on a per-test basis as healthcare practitioners order ColoSTAT tests, with Rhythm performing analysis and invoicing patients directly.
This structure aligns Rhythm’s cost base with actual testing volumes during the early commercialisation phase. The partnership is funded from existing operational budgets, requiring no additional capital to support implementation. Testing volumes remain uncertain and depend on healthcare practitioner adoption rates, which are not yet established.
CEO commentary on partnership rationale
Dr David Atkins, CEO & Managing Director of Rhythm Biosciences, highlighted the strategic value of the expanded 4Cyte relationship:
Dr David Atkins, CEO & Managing Director
“We have gained valuable experience working with the 4Cyte team with Genetype and are delighted to be expanding our relationship. This partnership enables healthcare practitioners to order ColoSTAT through the same systems they already use for routine pathology, removing a key barrier to adoption. With colorectal cancer screening participation in Australia remaining below 50%, there is a clear and urgent need for alternative screening pathways. This partnership positions ColoSTAT to be accessed through established pathology workflows and potentially address that unmet need at scale.”
The reference to the existing Genetype relationship indicates an established working relationship between the two organisations, now being extended to support ColoSTAT’s commercial distribution.
Next steps and what to watch
Rhythm and 4Cyte will now complete technical integration of ColoSTAT into 4Cyte’s clinical ordering systems and establish operational workflows for sample collection, transport, and results delivery. Commercial rollout timing depends on completion of this integration and operational readiness.
The company has stated it will provide updates on testing volumes and commercial progress as part of regular reporting. However, investors should note that testing volumes are uncertain, with no guarantee of revenue generation under the agreement. Actual testing volumes will depend on healthcare practitioner adoption rates, which are not yet established.
Integration timeline and early testing volume metrics will serve as key indicators of commercial traction. The agreement’s variable cost structure means that early-stage testing volumes will directly impact revenue generation without imposing fixed cost burdens on the company.
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