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PolypDx™ for Healthcare Professionals

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 individuals at average to moderate risk for colorectal cancer.

Screening should be performed every 1-3 years for those between 50 and 74 years.

 

Performance

PolypDx™ was developed and validated in a large-scale (nearly 1000-patient) clinical trial in Alberta, Canada in conjunction with University of Alberta, the Edmonton Colon Cancer Screening Program (SCOPE), and Alberta Health Services (formerly, Capital Health). 

At a high specificity of 91%, PolypDx™ detects 43% of the colonic adenomatous polyps, a significantly higher sensitivity than other fecal-based tests for the detection of adenomatous polyps.

    PolypDx™

Hemoccult II

Hemoccult ICT

MagStream HemSp/HT

Sensitivity 43.1% 3.8% 17.6% 21.2%
Specificity 91.3% 99.4% 97.0% 91.7%
PPV 59.5% 66.7% 64.3% 44.0%
NPV 84.4% 77.1% 79.6% 79.1% 


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 clinically 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 a polyp and further investigation, such as a follow up with a colonoscopy, is strongly recommended.
  • A NEGATIVE result would indicate the patient is less likely to have a polyp. Although symptomatic patients may still require further investigation, regular interval surveillance for polyp detection is recommended.

How to order PolypDx™

PolypDx™ is currently available as a laboratory-developed test through Clinical Laboratory Improvement Amendments (CLIA) certified laboratories in the U.S. and is highly adaptable to standard medical laboratory workflows.

If you are in the following:

Please contact:

Connecticut, Delaware, District of Columbia, Florida, Kentucky, Maryland, New York, New Jersey, Ohio, Pensylvania, Virginia, West Virginia Atlantic Diagnostic Laboratories (267) 525-2470
Other U.S. states Metabolomic Technologies Inc. (587) 772-1684
Outside the United States Metabolomic Technologies Inc. +01 (587) 772-1684