Rhythm Biosciences (ASX:RHY) has announced that Adelaide’s Lyell McEwin Hospital will be the first study site for the 1,000-patient prospective clinical trial of its blood test, ColoSTAT, for the early detection of colorectal cancer.
The site's principal investigator is the hospital's director of gastroenterology, Professor Rajvinder Singh, who is a committee member of the American Society of Gastrointestinal Endoscopy’s International Initiative and past chair of the Australian Gastroenterology Endoscopic Association.
“Surgical interventions for colorectal cancer are much more effective when the cancers are detected early stage, particularly when they can be removed during a colonoscopy procedure,” said Professor Singh.
“There is a real need for inexpensive, minimally invasive screening tests that will attract the public and I am pleased to have been invited to be principal investigator in the critical clinical evaluation of this new test.”
“We are delighted to have a clinician of Prof Singh’s stature to lead this important study,” said Rhythm CEO Glenn Gilbert.
Rhythm has appointed clinical research organisation Plunkett Consulting Group to manage the operations of the trial and provide rigour to the recruitment, monitoring and data collection, alongside Sonic Clinical Trials (SCT) who will facilitate the sample collection, processing, analytical testing, recording of results, transport and storage across the various participating clinical trial sites.
Sonic Clinical Trials is a wholly owned subsidiary of Sonic Healthcare (ASX:SHL), one of the world's largest medical diagnostics companies.
“Sonic Clinical Trials providing the central laboratory services for Study 7 is an ideal testing ground with our ColoSTAT technology being integrated into Sonic’s existing testing platforms, as it will with those of other pathology labs globally,” said Mr Gilbert.
“Using experienced partners such as Sonic Clinical Trials and Plunkett Consulting Group, increases our confidence in the robustness of this trial and will mitigate the risks around trial quality and control of samples.”
The study will investigate the diagnostic performance of the ColoSTAT In Vitro Diagnostic relative to colonoscopy (Primary endpoint). Secondary endpoints include assessing the ability of ColoSTAT to detect advanced adenomas and a comparison of its performance with the currently used Faecal Immune Test.