Rhythm’s lead biomarker successfully differentiates between cancer and healthy samples
Rhythm Biosciences Limited (ASX:RHY) today announced that recent testing has indicated that the new antibodies for the key lead biomarker used in its ColoSTAT® test can successfully differentiate between cancer and healthy samples, and the test has now been optimised.
Making this distinction marks a crucial step for ColoSTAT®, Rhythm’s global, low-cost, lifesaving blood test for the early detection of colorectal cancer — the third biggest cause of cancer-related deaths globally.
ColoSTAT® is Rhythm’s lead product and is intended to be a simple, affordable, minimally invasive and effective blood test for the early detection of bowel cancer for the global mass market.
Rhythm CEO Glenn Gilbert said, “This is a significant milestone for RHY and the ColoSTAT® test development. Taken together, the successful progression of these antibodies, and confirmation that the test discriminates between cancer and healthy samples, creates major value for Rhythm. This success buoys us for further development of the remaining biomarkers that will make up the final ColoSTAT® test.
“The optimisation of this key lead biomarker is a critical developmental cornerstone for the ColoSTAT® test. Previous antibodies were not able to distinguish between cancer and healthy samples. Achieving that ability for such a key biomarker is a hugely exciting milestone for us.”
RHY continues to work on developing a highly effective, clinically useful ColoSTAT® test through the development, optimisation, performance verification and validation of the reagents that will form the core components of the final test, which will be used in the company’s upcoming clinical trial (Study 7) and subsequent applications for CE Mark and TGA registration.
“Looking ahead, we have identified preferred suppliers, consultants, manufacturers and have established a clear sequence of activities to further de-risk the science behind ColoSTAT®, and achieve successful registration,” Mr Gilbert added.
It is expected to be comparable to, if not better than, the current standard of care, the faecal immunochemical test (FIT), at a lower cost.
ColoSTAT® also provides an alternative for those who choose not to, or are unable to, be assessed using standard screening programs. It was designed to be used easily by laboratories without the need for additional operator training or additional infrastructure.
ColoSTAT® has the potential to play an important role in reducing the morbidity and mortality rates and healthcare costs associated with colorectal cancer. Globally, over 850,000 people die from colorectal cancer each year.