Rhythm Biosciences has announced that its second-generation ColoSTAT kit for colorectal cancer detection has shown significant performance improvements over the original version. Preliminary testing of the new multiplex Alpha antibody kit on 200 patient serum samples has yielded superior analytical results compared to the first-generation product. This advancement marks a crucial step toward commercialization, reducing development risk and potentially offering a more accessible screening option.
The ColoSTAT test measures five protein biomarkers indicative of colorectal cancer. The updated kit integrates these measurements into a single reaction for each patient blood sample, streamlining the process and enhancing reproducibility. According to Rhythm Biosciences Managing Director Dr. David Atkins, combining multiple antibodies into a single reaction vessel could generate unexpected results, and the evaluation of the Alpha kit has always been an important milestone to achieve.
Enhanced Assay Performance
The second-generation kit was developed and manufactured by Quansys Biosciences in the US, with the goal of improving upon the original ColoSTAT assay's performance. "The goal was to successfully re-engineer the assay to increase quality and make the assay easier to use and more reproducible while maintaining at least the performance of our first generation ColoSTAT assay," Dr. Atkins stated. This enhancement is expected to simplify the testing process and improve the reliability of results.
ColoSTAT as an Alternative Screening Tool
Colorectal cancer is a significant global health concern, with an estimated 1.9 million new cases and 935,000 deaths annually. Early detection is critical, as intervention at early stages can lead to a cure in over 90% of new cases. ColoSTAT aims to provide an alternative screening method for individuals who are unable or unwilling to participate in current screening programs, such as colonoscopies.
Rhythm Biosciences is now finalizing plans to launch a beta version of the assay in the coming weeks. This beta version will be used to develop a commercial version of the algorithm and provide further verification and validation. The company is also in the process of finalizing plans for assay validation using independent clinical samples and plans to announce clinical partners in the near future.
