Rhythm Biosciences completes final validation of ColoSTAT colon cancer test

• Rhythm completes final full system validation of ColoSTAT for the kits, algorithm and instrumentation using range of clinical samples
• Validation shows simple blood test to detect colon cancer will meet needs for intended clinical indication
• Request submitted to National Association of Testing Authorities for addition of ColoSTAT to Rhythm’s laboratory accreditation

Special Report: Rhythm Biosciences has reached a major milestone with ColoSTAT, its second-generation blood test for colon cancer. Final validation completed with data submitted for inclusion in lab accreditation to support commercialisation.

Predictive cancer diagnostics company Rhythm Biosciences (ASX:RHY) has completed in-house laboratory validation of the final, highest quality ColoSTAT tests produced by its manufacturing partner Quansys Biosciences, using a scalable manufacturing process.

Analytical testing was undertaken across 450 sample replicates under different conditions confirming Rhythm’s proprietary ColoSTAT was a highly robust and reproducible test demonstrating strong clinical performance.

Following analysis of more than 300 clinical samples, ColoSTAT achieved:

• 91% sensitivity for detecting colorectal cancer in individuals over 45 years of age, considered at higher risk
• 98% negative predictive value, indicating suitability for safe triage of symptomatic patients

ColoSTAT could also provide a safe and effective alternative for symptomatic individuals who prefer not to undergo stool-based testing, supporting informed decisions regarding colonoscopy.

Laboratory validation data has now been submitted to the National Association of Testing Authorities (NATA) to add ColoSTAT to Rhythm’s existing ISO15189 test portfolio in preparation for commercialisation.

‘Critical validation milestones”

Managing director and CEO Dr David Atkins said the company was delighted to have achieved these “critical validation milestones” and to report promising performance that reinforces ColoSTAT’s potential to improve early detection of colorectal cancer.

“Our focus now turns to commercial pathways to bring this much-needed diagnostic to market,” he said.

“We also look forward to adding new data to our evidence base and announcing important clinical partnerships in the near future.”

Rhythm said it remained committed to driving ColoSTAT toward regulatory approval and commercial roll-out.

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