Rhythm Biosciences’ new clinical trial shows increases accuracy for their simple cancer blood test

Colorectal cancer is the second leading cause of cancer-related death in Australia. This can be attributed to the silent nature of the disease, not causing symptoms until tumours are well established. 

The Australian Government is all too aware of this, having created the National Bowel Cancer Screening Program with the goal of early detection to circumvent preventable deaths. The Program sends testing kits to Australians on their 50th birthday, and encourages regular testing every few years from the ages of 50 to 74. 

Designed to detect blood in the stool, fecal occult blood tests (FOBTs) are the current standard of care for colorectal cancer detection. Definitive diagnosis is made with a colonoscopy which is highly invasive. 

Unfortunately the Government’s efforts aren’t as successful as they’d hoped, with only 43.5% of people returning their testing kits in 2018-2019. 

In an effort to combat this, diagnostic tech company Rhythm Biosciences (ASX: RHY) have developed a simple blood test designed to detect colorectal cancer. The ColoSTAT test is cost effective and minimally invasive, detecting biomarkers of colorectal cancer in the blood. The test works with existing laboratory equipment and has been clinically validated to perform better than current standard of care tests with more accuracy. 

The Company has just completed a clinical trial which confirmed the test’s high sensitivity and specificity in detecting biomarkers of cancer. The study evaluated 989 samples, 737 of which made up the final data set. ColoSTAT again outperformed the current faecal test in this latest study with 35% more accuracy. Previous to this, the Company had referenced a study figure of 33%. The current study also confirmed that ColoSTAT was more accurate at detecting advanced adenomas (precursor to cancer) than the standard of care test. 

CEO and Managing Director, Glenn Gilbert said: “We are extremely pleased with the significant positive outcomes from this study. It further supports our conviction that ColoSTAT has the potential to transform the way colorectal cancer is detected, on a global scale. 

“We express our gratitude to the patients and thank our partners for the work completed thus far, including our Clinical Research Organisation, Accelagen, our statisticians, Statistical Revelations, the individual trial sites and our analytical testing partner Sonic Clinical Trials (a 100% owned subsidiary of Sonic Healthcare ASX: SHL). 

“To achieve such a strong overall performance result and further, the meaningful clinical significance versus the current market standard, FIT, further strengthens Rhythm’s position for significant positive outcomes moving forward, both economically and socially.”

No doubt the study results bode well for Rhythm. The Company estimates the market opportunity for ColoSTAT and similar biomarker cancer detection tests to exceed USD $38 billion, with the potential to reach over 771 million people to screen for colorectal cancer. 

The Company is hoping to commercialise the test by late 2022. The test is already patented in multiple jurisdictions and has received the CE Mark for use in Europe. 

Keenly awaiting the chance to start generating sales, Rhythm rounded out the half year ended 31 December 2021 with $5.5 million in cash