Clinical Trials

1000-Patient Discovery Trial

Our flagship product, a highly sensitive urine test to identify adenomatous polyps, was developed in a 1000-patient discovery trial. Prospective urine and stool samples were collected from 876 participants undergoing colonoscopy examination in a colon cancer screening program at the University of Alberta, Canada.  Colonoscopy reference standard identified 633 participants with no colonic polyps and 243 with colonic adenomatous polyps. One-dimensional NMR spectra of urine metabolites were analyzed to define a diagnostic metabolomic profile for colonic adenomas. A urine metabolomics diagnostic test, PolypDx™, was developed that identifies patients with colonic adenomatous polyps with a greater level of sensitivity than fecal-based tests.

Publication: 

Wang H, Tso V, Wong C, Sadowski D, Fedorak RN. Development and validation of a highly sensitive urine-based test to identify patients with colonic adenomatous polyps. Clin Transl Gastroenterol 2014;5:e54. 

Validation Trial on a Clinical Platform

The PolypDx™ test was clinically validated in Canada in a 685 patient study of patients enrolled in a colorectal cancer screening program to undergo colonoscopy examination. The trial results validated a clinically-scalable mass spectrometry based test that identifies patients with adenomatous polyps at a higher level of sensitivity than fecal based testing.

Publication:

Deng L, Chang D, Foshaug RR, Eisner R, Tso VK, Wishart DS, Fedorak RN. Development and Validation of a High-Throughput Mass Spectrometry Based Urine Metabolomic Test for the Detection of Colonic Adenomatous Polyps. Metabolites, June 22, 2017, 7(3), 32 

Validation Trial in Another Population

The performance of PolypDx™ was validated in a three-year, 1000-patient clinical trial in China in collaboration with the University of Alberta, the Chinese Center for Disease Control and Prevention (CDC-China), and BGI Shenzhen, (formerly, the Beijing Genomics Institute). Prospective urine samples were collected from 1000 participants undergoing colonoscopy examination at Minhang District, Shanghai Centre for Disease Control and Prevention. One-dimensional NMR spectra of urine metabolites were analyzed to determine the concentrations of key metabolites used in PolypDx™. The trial validated our novel urine-based metabolomic diagnostic test for the detection of adenomatous polyps in a population with different diets and background than the original discovery trial.

Publication:

Deng L, Fang H, Tso VK, Sun Y, Foshaug RR, Krahn SC, et al. Clinical validation of a novel urine-based metabolomic test for the detection of colonic polyps on chinese population. International Journal of Colorectal Disease 2017;32:741-3.

Improved Detection for Colorectal Cancer

A biomarker discovery study was performed in collaboration with the University of Alberta, and Memorial Sloan Kettering Cancer Center on urine samples of 342 participants (colorectal cancer, 171; healthy controls, 171). Targeted liquid chromatography-mass spectrometry (LC-MS) was performed to quantify 140 highly valuable metabolites in each urine sample. Potential biomarkers for colorectal cancer were identified by comparing the metabolomic profiles from colorectal cancer versus controls. A panel of 17 metabolites was identified as possible biomarkers for colorectal cancer. Using only two of the selected metabolites, namely diacetylspermine and kynurenine, a predictor for detecting colorectal cancer was developed with an AUC of 0.864, a specificity of 80.0%, and a sensitivity of 80.0%.

Publication:

L Deng, K Ismond, Z Liu, J Constable, H Wang, OI Alatise, MR Weiser, TP Kingham, D Chang Urinary Metabolomics to Identifty a Unique Biomarker Panel for Detecting Colorectal Cancer: A Multicenter Study Cancer Epidemiology, Biomarkers & Prevention, August, 2019, 10.1158/1055-9965.EPI-18-1291

Real-world Assessment of PolypDx™ in Canada

Our PolypDx™ test is currently undergoing an assessment by a Health System in Canada. The project, called the Canadian Assessment of PolypDx™ (CAP), engages expert physicians, clinicians, patients and laboratory specialists to assess colorectal cancer screening in patients in five regions located throughout Alberta. A national working group of key provincial and national leaders in colorectal cancer screening will assess the results of this screening strategy for use throughout Canada. With the leadership of key stakeholders, this project brings a made-in-Alberta technology to Albertans and serves as a launching pad for the rest of Canada.

Currently Enrolling