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

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 r...

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Bibliographic Details
Published in:Molecular diagnosis & therapy 2017-04, Vol.21 (2), p.225-232
Main Authors: Lamb, Yvette N., Dhillon, Sohita
Format: Article
Language:English
Subjects:
Adis Diagnostic Profile
Biomarkers
Biomedical and Life Sciences
Biomedicine
Blood
Blood tests
Cancer
Cancer Research
Clinical trials
Colon
Colon cancer
Colonoscopy
Colorectal cancer
Colorectal carcinoma
Cost analysis
Deoxyribonucleic acid
DNA
DNA methylation
Endoscopy
Feces
Human Genetics
Laboratory Medicine
Medical screening
Molecular Medicine
Patients
Pharmacotherapy
Plasma
Polymerase chain reaction
Sensitivity
Sigmoidoscopy
Tumors
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Summary: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.
ISSN:1177-1062
1179-2000
DOI:10.1007/s40291-017-0259-y