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PolypDx™ for Clinicians

Richard N. Fedorak, MD, FRCPC, FRCP(London), FRSC

Dean, Faculty of Medicine & Dentistry, University of Alberta

 

PolypDx™ is the first and only urine-based test with a high accuracy for detection of adenomatous polyps – the precursor to colorectal cancer.

Intended use

PolypDx™ is intended for asymptomatic patients of average risk for development of colorectal cancer.

Screening should be performed regularly according to local guidelines.

 

Performance

PolypDx™ was developed and validated in conjunction with University of Alberta, the Edmonton Colon Cancer Screening Program (SCOPE), and Alberta Health Services . Prospective urine and stool samples were collected from participants undergoing colonoscopy examination in a colon cancer screening program, from April 2008 to October 2009 at the University of Alberta. Colonoscopy reference standard identified 530 participants with no colonic polyps or only hyperplastic polyps and 155 participants with colonic adenomatous polyps or colorectal cancer. Liquid chromatography–mass spectrometry (LC-MS) was used to quantify urine metabolites. The urine test identified patients with colonic adenomatous polyps at a much higher sensitivity than fecal-based tests.


Reference:
 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 

PolypDx™ has been validated through multiple clinical studies, in populations in both North America and China.

Clinical Trial in Canada

PolypDx™ was originally developed on Nuclear Magnetic Resonance (NMR) platform. Prospective urine and stool samples were collected from 876 participants undergoing colonoscopy examination in a colon cancer screening program, from April 2008 to October 2009 at the University of Alberta. 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 metabolomic diagnostic test was developed that identifies patients with colonic adenomatous polyps with a greater level of sensitivity than fecal-based tests.


Reference:
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. 

Clinical Trial in China

The performance of PolypDx™ was further validated in a three-year, 1000-patient clinical trial in China in collaboration with the University of Albertathe 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, from March 2013 to July 2014 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™. Here, we validated a novel urine-based metabolomic diagnostic test for the detection of adenomatous polyps on Chinese population.


Reference:
 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.

The Science Behind the Test

PolypDx™ is a metabolomics-based screening test designed for high-throughput screening, using Liquid chromatography–mass spectrometry (LC-MS) technology.

PolypDx is based on the analysis of key metabolomic biomarkers in urine. The biomarker measurement data are interpreted by a proprietary algorithm which generates the PolypDx™ test result.

 

How to Interpret PolypDx™ Results

PolypDx™ uses an algorithm to compare the urine metabolite concentrations and specific patient information to determine the likelihood of an adenomatous polyp being present.

  • A POSITIVE result would indicate the patient is likely to have an adenomatous polyp. Further followup with physician is recommended. 
  • A NEGATIVE result would indicate the patient is less likely to have an adenomatous polyp. Regular screening is recommended. Patients may still require further investigation. Clinical correlation is required.

How to order PolypDx™

PolypDx™ is currently available in the United States as a laboratory-developed test through a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.

For more information on how to order the test for your patients, please see GetPolypDx.com