Breakthrough for Rhythm's next-gen bowel test
Performance meets clinical requirements for symptomatic patient testing use case
Commercialisation steps underway as ColoSTAT kit transitioned to final production validation state
Special Report: Rhythm Biosciences has announced that its second-generation ColoSTAT blood test detects colorectal cancer consistently across all stages of the disease, marking an important milestone as the company prepares for commercialisation later this year.
Following completion of ColoSTAT Beta kit verification and validation announced in May, the Rhythm Biosciences (ASX:RHY) development team has received a batch of ColoSTAT kits produced by Quansys Biosciences using the final manufacturing process.
As part of the validation process, blood samples from 300 patients, ranging from those without bowel cancer to those with stage I to IV of the disease, were tested to assess how well ColoSTAT works across all stages.
While further studies will be completed, the results show the test is equally effective at detecting colorectal cancer at every stage, which is an important finding given its intended use for symptomatic patients who could have either early- or late-stage disease.Other cancer tests often struggle to detect early-stage disease, so the fact that ColoSTAT performs well at this stage is seen as particularly important.
The predictive cancer diagnostics technology company expects to finalise validation of the kits, algorithm, and instrumentation in the near term, ahead of a submission to the National Association of Testing Authorities (NATA) in Australia to include ColoSTAT in its ISO15189 laboratory test portfolio.
NATA is Australia's primary accreditation body for laboratories and testing facilities.
Commercial launch of ColoSTAT is planned for later in CY25, subject to NATA regulatory approval.
Watch: CEO David Atkin's talks about early cancer detection.
'Establishing a clinically useful product'
ColoSTAT is a simple, minimally invasive blood test designed for people unwilling or unable to undergo traditional screening methods for colorectal (bowel) cancer, the world's second leading cause of cancer deaths but highly treatable when detected early.
The test identifies specific protein biomarkers in the blood that indicate the likelihood of colorectal cancer.
The second-generation ColoSTAT blood test involved a redesign of the assay from a single-plex into a multiplex format with several objectives including:
Simplify completion of the test for a routine laboratory Reduce turnaround times (TAT) Improve the quality and performance of the assay Reduce overall cost of goods for the assay
Clinical advisor Dr Andy Feber said demonstrating performance across the full spectrum of neoplastic conditions was essential for a clinically useful product.
'Establishing ColoSTAT performance across the entire range of neoplastic conditions is an important requirement for a clinically useful product,' he said.
'I'm pleased to see this important milestone has been achieved.'
This article was developed in collaboration with Rhythm Biosciences, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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