Rhythm Biosciences Achieves Key Milestone with Colorectal Cancer Assay Alpha Kit
RHYTHM BIOSCIENCES LIMITED (RHY) Share Update August 2024 Tuesday 27th
Rhythm Biosciences Reaches Major Milestone with New Colorectal Cancer Assay
Rhythm Biosciences Ltd (ASX: RHY) has announced a significant advancement in its colorectal cancer diagnostics technology with the delivery of the Alpha version of its multiplex antibody detection kits.
Instant Summary:
- Received the first batch of Alpha version multiplex antibody detection kits.
- Kits are functional prototypes for colorectal cancer detection using blood samples.
- The new format combines five separate assays into a single reaction.
- Initial Alpha test results have exceeded critical design inputs.
- Company is revising regulatory strategy and commercial plan for market launch.
Product and Market Update
Rhythm Biosciences Ltd (ASX: RHY), a transformative, predictive cancer diagnostics technology company, has announced the receipt of the first batch of the Alpha version of its multiplex antibody detection kits. These kits, developed and manufactured by Quansys Biosciences in the USA, are functional prototypes designed for the detection of colorectal cancer using patient blood samples.
This milestone marks a significant step forward for Rhythm Biosciences, paving the way for further in-house assay testing ahead of final design iteration and clinical validation. The ultimate goal is to launch a next-generation colorectal cancer diagnostic kit commercially.
Innovative Assay Design
The new multiplex assay kits integrate five separate antibody-based assays, previously part of the ColoSTAT® assay, into a single reaction per patient blood sample. Developed in collaboration with Quansys, the new format leverages proprietary technology to enhance assay reliability. The improved assay is expected to meet customer requirements by reducing turnaround time, increasing throughput, and lowering the overall cost of goods.
Initial Alpha test results have met critical design inputs, with outcomes exceeding initial expectations. Dr. David Atkins, CEO of Rhythm, expressed his satisfaction with the progress, while Dr. Kyle Berg, R&D Manager at Quansys, highlighted the complexity and success of the assay design.
Future Plans and Regulatory Strategy
Rhythm Biosciences continues to target the launch of a novel, blood-based general colorectal cancer screening assay. The company is exploring clinical applications as intermediate steps towards this goal, focusing on colonoscopy triage to prioritize individuals scheduled for colonoscopy.
Customer input is being collected to prepare final design inputs for these near-term opportunities in key target geographies. Additionally, Rhythm is engaging experienced consultants to revise and redesign its regulatory strategy, ensuring an appropriate path to market. Relevant announcements will be made as the revised strategy and commercial plan are completed.
The announcement of the Alpha version of the colorectal cancer assay kit is a positive development for Rhythm Biosciences. This milestone indicates significant progress towards the commercial launch of a novel diagnostic tool, which could enhance the company's market position. The improved assay's potential to reduce costs and increase efficiency is likely to attract investor interest and support commercial adoption.
Investor Reaction:
Analysts are likely to view this development favorably, recognizing the potential for Rhythm Biosciences to make a significant impact in the colorectal cancer diagnostics market. The positive initial test results and the company's proactive approach to regulatory strategy are expected to boost investor confidence.
Conclusion:
Investors should keep an eye on Rhythm Biosciences as it progresses towards the commercial launch of its new colorectal cancer assay kit. The company's innovative approach and commitment to improving cancer diagnostics could lead to significant advancements in the field. Stay informed and consider the potential long-term benefits of this promising technology.