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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 diagnostic 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™ is the first and only urine test that detects adenomatous polyps, the precursor to colorectal cancer, with a high sensitivity.

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

 

Clinical Trial in Canada

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). PolypDx™ was shown to have a greater level of sensitivity (83%) in the detection of colonic adenomatous polyps, than other fecal-based tests.

    PolypDx™

Hemoccult II

Hemoccult ICT

MagStream HemSp/HT

Sensitivity  82.7% 2.5% 7.6% 11.9% 
Specificity  51.2%  99.5% 96.8% 94.3% 

 

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 Alberta, the Chinese Center for Disease Control and Prevention (CDC-China), and BGI Shenzhen, (formerly, the Beijing Genomics Institute).

    PolypDx™

Hemoccult II

Hemoccult ICT

MagStream HemSp/HT

Sensitivity 82.6% 2.5% 7.6% 11.9% 
Specificity 42.4%  99.5% 96.8% 94.3% 


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
Arizona, Nevada

Lab Express (702) 643-5227; or

Metabolomic Technologies Inc. (587) 772-1684

Other U.S. states Metabolomic Technologies Inc. (587) 772-1684
Outside the United States Metabolomic Technologies Inc. +01 (587) 772-1684

 

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