Rhythm Biosciences receives UKCA mark for ColoSTAT colorectal blood test kit

A simple blood test used for the detection of colorectal cancer has achieved UK Conformity Assessed (UKCA) marking for developer Rhythm Biosciences (ASX: RHY).

The regulatory milestone proves the ColoSTAT kit fully conforms with the European Directives for IVD Medical Devices (98/79/EC) and moves it a step closer to commercialisation in the UK.

The achievement follows analytical testing and adherence to design and development procedures and has been shown to be compliant for its intended purpose.

Affixing the UKCA mark is a key component in Rhythm’s commercial plan and priority market entry strategy.

It will enable the company to commercialise and sell ColoSTAT to an addressable screening population of about 24 million people across the UK.

Chief commercial officer Elena Deak said the milestone validated the company’s commercial pathway into global markets.

“Importantly, we expect the market size to continue expanding over time as various bodies encourage earlier age screening.”

Most common cancer

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

Early detection and intervention can lead to 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.

These are predominantly administered with a faecal immunochemical test (FIT) for the assessment of colorectal cancer risk, with a positive result referred for a colonoscopy.

FIT analyses the presence of blood in faeces, however this can occur for several reasons other than cancer, therefore it is not considered to be an accurate test for cancer.

Fit for purpose kit

Rhythm aims to transform the global colorectal cancer diagnostics market with its simple,
low-cost blood test which is fit for purpose (meaning it is designed to actually detect colorectal cancer).

The ColoSTAT test kit measures five protein biomarkers which indicate the presence of cancer cells.

It can be used as an alternative for individuals unwilling or not able to participate in current screening programs.

ColoSTAT is based on research from Australia’s Commonwealth Scientific and Industrial Research Organisation (CSIRO) and is patent protected internationally.

Ms Deak said it has the potential to play a key role in reducing the mortality rate and healthcare costs associated with colorectal cancer.