Rhythm Biosciences Limited (ASX:RHY) has welcomed new trial member Monash Health in joining its prospective clinical trial of ColoSTAT – a global lifesaving blood test for the early detection of colorectal cancer.
The trial involves a prospective, cross-sectional study to evaluate the diagnostic performance of the ColoSTAT In Vitro Diagnostic relative to the primary endpoint of a colonoscopy.
Secondary end points of the study include assessing the ability of ColoSTAT to detect advanced adenomas and a comparison of the performance of ColoSTAT with the used Faecal Immune Test (FIT).
“Important boost to recruitment participants”
Rhythm’s chief executive officer Glenn Gilbert said: “Monash Health services a significant patient population which will allow us to access a broad spectrum of people for recruitment.
“Coupled with Dr Pianko’s well recognised experience in and commitment to colonoscopy and his effective track record of clinical trial execution, Monash Health’s joining of our trial provides an important boost to recruiting participants to the study by the end of the year.”
Recruitment for the trial of around 1,000 patients is expected to be completed at the end of 2019 and will form a key component for both CE Mark & TGA registration as well as the approval to market ColoSTAT in Australia and Europe in 2020.
Continued work with global parties
The first patients for the trial have also been recruited by Monash Health, which is the second clinical trial site.
With more than 16,000 staff working at over 40 locations, Monash Health is Victoria’s largest public health service providing health care to 25% of Melbourne’s population.
Additionally, Rhythm continues to work with global parties on assay development, optimisation and clinical utility of the reagents that will form core components to the final ColoSTAT test.