Rhythm Biosciences’ 2G ColoSTAT colorectal cancer detection kit outperforms predecessor in key testing

Medical diagnostics company Rhythm Biosciences (ASX: RHY) has confirmed that the second version of its ColoSTAT kit for the detection of colorectal cancer has shown significant outperformance on the original.

Preliminary testing of 200 patient serum samples using the new multiplex Alpha antibody kit has revealed superior analytical results compared to tests performed on the first-generation product.

Testing using the Alpha kits took place on 100 samples from cancer patients and 100 controls and aimed to generate data to create a new prototype algorithm designed to separate cancer from non-cancer samples.

Prototype algorithm

Rhythm managing director Dr David Atkins welcomed the new findings.

“The second generation ColoSTAT multiplex assay kits combine five separate antibody-based assays, which previously constituted the original ColoSTAT assay, into a single reaction for each patient blood sample,” he said.

“It is well known that 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 for us to achieve.”

Improved performance

The new kit has been developed and manufactured by Quansys Biosciences in the US to supersede the performance of the original.

“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 said.

“This represents an important step forward and reduces a significant portion of development risk from the pathway to eventual commercialisation.”

Alternative test option

The ColoSTAT test kit, which measures five protein biomarkers that can indicate the presence of colorectal cancer cells, is an alternative for individuals unwilling or unable to participate in current screening programs.

Rhythm will be looking to launch a beta version of the assay in the coming weeks, which will be used to kickstart development of a commercial version of the algorithm and provide further verification and validation.

The company is also finalising plans for assay validation using independent clinical samples and plans to announce clinical partners in the near future.

Common cancer

Colorectal (or bowel) cancer is the third most common cancer in men and the second most common in women worldwide, accounting for an estimated 1.9 million new cases and approximately 935,000 deaths annually.

Early detection and intervention can lead to a cure in over 90% of new cases.

In an effort to reduce the global burden, many countries have introduced screening programs aimed at early detection.