Rhythm Biosciences Advances ColoSTAT® to Final Validation Stage, Targeting 2025 Commercial Launch

Key Highlights:

• Final ColoSTAT® kits show consistent detection of colorectal cancer from Stage I to IV.
• First batch of production-grade kits received; validation underway.
• Regulatory submission to NATA expected soon, with 2025 commercial launch timeline.
• Stock surged over 18% on news, reflecting market confidence.
   

Rhythm Biosciences Ltd (ASX: RHY) has achieved a pivotal milestone in its ColoSTAT® diagnostic journey, announcing that the latest version of its blood-based colorectal cancer test kit has advanced to the final production validation phase. This development, revealed in the company’s ASX update on Monday, August 4, marks a major step toward commercialisation of a test with potentially transformative impact in global cancer diagnostics.

Following completion of Beta kit validation, Rhythm has now received a batch of ColoSTAT® kits manufactured by U.S.-based Quansys Biosciences under the finalised production process. These kits are now undergoing internal validation testing to confirm clinical performance before submission to regulatory authorities.

“Establishing ColoSTAT® performance across the entire range of neoplastic conditions is an important requirement for a clinically useful product. I’m pleased to see this important milestone has been achieved,” said Dr Andy Feber, Clinical Advisor to Rhythm.

Broad Effectiveness Across All Cancer Stages

What makes this update particularly significant is the diagnostic consistency of ColoSTAT® across all four stages of colorectal cancer (CRC), based on a 300-patient sample cohort. Early-stage detection has historically been a challenge in oncology diagnostics, making Rhythm’s latest findings especially promising. The test demonstrated equally effective results in detecting CRC from Stage I through IV — a critical attribute for widespread clinical adoption, especially for symptomatic patients with varying disease progression.

With CRC being the second leading cause of cancer-related deaths globally, early and accurate detection remains a central objective for healthcare systems. ColoSTAT® is designed to fill a significant gap, especially for patients unable or unwilling to participate in conventional screening programs such as colonoscopies or faecal immunochemical tests (FIT).

Final Validation and Regulatory Pathway

Rhythm is preparing for submission to NATA (National Association of Testing Authorities) to include ColoSTAT® in its ISO15189 laboratory test portfolio, an essential regulatory hurdle prior to full-scale commercial deployment. According to the company, the commercial launch is targeted for late 2025, contingent on NATA approval timelines.

This final internal validation will include not just the kits, but also associated algorithms and instrumentation. The company is expected to report results shortly — news that could serve as a further catalyst for market momentum.

Market Impact and Commercial Outlook

Following the ASX announcement, RHY shares jumped 18.33%, reaching $0.071 by late morning trading on August 4. The surge reflects investor confidence in the commercial viability of ColoSTAT®, especially considering the test’s wide potential application across primary care, specialist clinics, and potentially global markets.

Rhythm’s total market cap now stands at $20.17 million, with approximately 284 million ordinary shares on issue.

Strategic Positioning in Global Oncology

Rhythm’s value proposition is rooted in simplicity and scalability. The blood-based ColoSTAT® test uses five specific protein biomarkers to detect CRC, enabling a more patient-friendly alternative to traditional screening protocols. Backed by intellectual property from CSIRO, the technology is protected internationally and aligns with broader healthcare trends prioritising early detection and preventative care.

Moreover, Rhythm has positioned itself for broader market impact through its association with geneType™, a platform offering multi-disease genetic risk assessments. This complementary approach reinforces the company’s focus on precision medicine and preventative diagnostics.

At the time of writing, RHY shares were trading at $0.071, up 18.33% on the day.