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Epi proColon® 2.0 CE: A Blood-Based Screening Test for Colorectal Cancer

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Abstract

Epi proColon® 2.0 CE is a blood-based test designed to aid in the early detection of colorectal cancer. The test comprises a qualitative assay for the polymerase chain reaction (PCR) detection of methylated Septin9 DNA, the presence of which is associated with colorectal cancer: however, positive results should be verified by colonoscopy or sigmoidoscopy. Epi proColon® 2.0 CE discriminated between patients with colorectal cancer and healthy controls with high clinical sensitivity and specificity in pivotal case-control studies. The sensitivity of the test did not appear to be affected by the tumour location or by patient age or gender. In addition, limited data suggest that Epi proColon® 2.0 CE discriminated between patients with colorectal cancer and healthy controls with higher sensitivity and generally similar specificity to that of the faecal immunochemical test, and with higher sensitivity and specificity to that of the guaiac-based faecal occult blood test (statistical data not available). In an observational study, most patients who refused colonoscopy for screening accepted a non-invasive test option as an alternative, and preferred Epi proColon® 2.0 CE over a stool-based test. Large prospective trials of Epi proColon® 2.0 CE in a screening setting will be required to further elucidate the cost-effectiveness of the test. Nevertheless, currently available data suggests that Epi proColon® 2.0 CE has the potential to be a sensitive and convenient screening option for patients refusing screening by colonoscopy.

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Acknowledgements

During the peer review process, the manufacturer of the Epi proColon® 2.0 CE test was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Yvette N. Lamb & Sohita Dhillon

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  1. Yvette N. Lamb
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  2. Sohita Dhillon
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Correspondence to Yvette N. Lamb.

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The preparation of this review was not supported by any external funding.

Conflict of interest

Yvette Lamb and Sohita Dhillon are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: A. Nicolini, School of Medicine, University of Pisa, Pisa, Italy; E. Danese, Department of Neuroscience, Biomedicine and Movement, Clinical Biochemistry Section, University of Verona, Verona, Italy.

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Lamb, Y.N., Dhillon, S. Epi proColon® 2.0 CE: A Blood-Based Screening Test for Colorectal Cancer. Mol Diagn Ther 21, 225–232 (2017). https://doi.org/10.1007/s40291-017-0259-y

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  • DOI: https://doi.org/10.1007/s40291-017-0259-y

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