Rhythm hits 2024 key milestones, targets 2025 launch of next-gen bowel cancer test

Predictive cancer diagnostics company Rhythm Biosciences reports it has attained all key milestones for 2024.

Rhythm is celebrating after attaining key milestones in 2024. Pic via Getty Images

• Rhythm Biosciences reports it has attained all key milestones for 2024

• Company receives delivery of second generation ColoSTAT beta release candidate multiplex kits

• Rhythm has a market-entry roadmap for second generation ColoSTAT Assay with commercial rollout planned for 2025

Predictive cancer diagnostics company Rhythm Biosciences (ASX:RHY) is ending 2024 on a high reporting it has attained all key milestones for the year, including advancing the second generation of its lead asset the ColoSTAT bowel cancer screening blood test.

ColoSTAT detects five specific protein biomarkers that indicate the likelihood of colorectal (bowel) cancer, which is the second leading cause of cancer deaths globally but if diagnosed early curable.

In its September quarterly update released to the market in October, Rhythm outlined three milestones it was looking to achieve by the end of CY24 including:

1. Receipt of R&D tax incentive (RDTI) return
2. Delivery of verified beta versions of newly designed multiplex kits to its Australian office
3. Market-entry roadmap for the colonoscopy triage application for the next generation ColoSTAT assay

Ticking off its first milestone Rhythm announced in November it had received its $3.23 million RDTI.

Second milestone also gets a tick

Rhythm said it had received the first batch of beta release candidate multiplex antibody detection kits developed and manufactured by its contract manufacturing organisation (CM0) Quansys Biosciences in the US.

Rhythm said the milestone paved the way for further testing and clinical validation of the second-generation diagnostic ColoSTAT test, targeting a commercial launch in 2H CY25.

The second-generation multiplex assay kits consolidate five separate antibody-based assays from the original ColoSTAT test into a single reaction for each patient sample.

Developed in collaboration with Quansys, the new format leverages proprietary technology to enhance ease of use and reliability for laboratories.

“The initial assay was a collection of five different test tubes which had to be run in order to complete the assay,” CEO Dr David Atkins told Stockhead recently.

“We took one step back to reconfigure the assay so it’s much simpler and more in line with what the laboratory industry uses.”

Third milestone market-entry roadmap for ColoSTAT assay completed

Rhythm said following strong progress being made with the second-generation assay, it had engaged experienced clinical, quality, and regulatory consultants in Australia, the UK, and the US to assist in finalising the most appropriate path to market in its three priority geographies.

The company said while it was still seeking approval for ColoSTAT under the usual regulatory pathways, it would pursue the more immediate path of selling the test as an in-house tool for use by in vitro diagnostic medical device (IVD) manufacturers.

Rhythm said as such it was positively progressing discussions with laboratory partners and aiming to progress to a commercial roll-out phase in H2 CY25.

Rhythm said it was confident the improved ColoSTAT assay would meet customer requirements, including three performance parameters identified as essential to support its commercial adoption including:

1. Reduced assay throughput and turnaround time
2. Improved reliability
3. A reduction in the overall cost of goods for the test

“This milestone is a major leap forward, bringing us closer to end-user clinical evaluation and commercialisation,” chief operating officer Nir Dvorski said.

$3.5 million capital raise to drive growth

In November Rhythm announced it had received commitments to raise $3.5 million in a placement supported by several new institutional, professional and sophisticated investors.

To ensure the company is using capital on strategically important activities the company said it had outsourced various services including the appointment of Acclime Corporate Services Australia as company secretary from January 6, 2025.

RHY said thanked outgoing joint company secretaries James Barrie and Andrea Steele. It said Steele would as general counsel of RHY.

While Rhythm Biosciences is a Stockhead advertiser at the time of publishing it did not sponsor this article.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Originally published as Rhythm hits 2024 key milestones, targets 2025 launch of next-gen bowel cancer test