1,000 Person Study
Biomarkers of colorectal neoplasia (Bio-ECON)
Sangui Bio is conducting a large colorectal polyp study that is now recruiting. The study obtains at-home stool and fingerprick dried blood samples. The stool samples will be subjected to microbiome analysis with our partner, Microba (www.microba.com). The whole blood fingerprick samples will be analysed using the Sangui Bio platform.
A significant advantage of at-home sampling before the colonoscopy is that people have not done the pre-colonoscopy bowel prep. This is the same as blood sampling in a real-world screening program.
Recruitment
Sangui Bio has partnered with the Colonoscopy Clinic in Brisbane to enable rapid recruitment. https://www.colonoscopyclinic.com.au/
The Colonoscopy Clinic performs 10,000 colonoscopies per year across 9 clinics in Brisbane. Approximately 60% of patients have polyps detected because they deal with a repeat clientele who are regularly screened because of previous polyps or family history. They see approximately 1,000 people/year who have large, advanced adenomas (>10mm) detected at their colonoscopy, which are classified as high risk. Their data shows that pre-cancerous polyp removal by colonoscopy reduces colorectal cancer by 99%. As well as assisting with recruitment the clinic provides high quality clinical data, which is essential to enable correct classification of participants. Recruitment via this pathway began in late Feb 2024 and up to date recruitment data is below.
Sangui Bio 1,000 Person Study Methodology
The clinical data obtained from the Colonoscopy Clinic enables Sangui Bio to stratify the study participants according to their polyp burden. Many participants are regularly screened by colonoscopy, so their cumulative polyp burden is known, as well as other clinically relevant issues such as family history of colorectal cancer.
The polyp study will obtain datasets from blood, stool microbiome and clinical data. Sangui Bio’s proprietary biomarker analysis technology enables the identification and quantification of over 4,000 proteins from a single dried blood spot. From these proteins, those that correlate with polyps, microbiome differences and clinical data will be selected as the initial biomarker panel.
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The biomarker panel will be selected to enable stratification of participants into high and low risk groups, based on their polyp burden. Higher polyp burden, especially large polyps, is a significant risk factor for transition to colorectal cancer.
To enable refinement and validation of the biomarker assay, there will be new cohorts of participants tested. In these cohorts, the results of the colonoscopy will not be known to Sangui Bio until after the biomarker test results have been completed and the risk stratification performed. This process determines the sensitivity, which refers to the test’s ability to correctly detect patients who do have high risk polyps (true positive). The test specificity relates to its ability to correctly identify patients with no polyps or low risk polyps (true negatives).
Colorectal Polyp Preliminary Data
The Sangui Bio technology platform has been used to analyse several blood sample sets from cohorts of patients undergoing colonoscopy. The clinical data on each patient’s polyp status was provided to Sangui Bio under the study ethics guidelines. To date, Sangui Bio has identified 328 proteins that were present at altered concentration in polyp vs control and statistically significant.
The dataset of 328 proteins were filtered using bioinformatic analysis and a subset of biomarkers selected. This subset of 30 biomarker proteins achieved a sensitivity of 91% and specificity of 77%, which exceeds the conventional stool blood test diagnostic performance.
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The current 1,000 person study will enable larger datasets to be obtained and Sangui Bio expects to identify additional biomarkers. These will form the basis of the initial assay development in the US lab.