Advanced Technology Laboratory, Molecular Diagnostics

New Test: Epi proColon Septin 9 Methylation Analysis

epi procolon collectionSpectrum Health Advanced Technology Laboratories are proud to announce that the first and only FDA-approved blood test for colorectal cancer screening is now available at Spectrum Health Molecular Diagnostics Laboratory. The  Epi proColon Septin 9 Methylation Analysis test is indicated to screen adults of either sex, 50 years or older, defined as average risk for colorectal cancer (CRC), who have been offered and have a history of not completing CRC screening.

The Epi proColon test is a qualitative in vitro diagnostic test for the detection of methylated Septin 9 DNA in EDTA plasma derived from patient whole blood specimens. Methylation of the target DNA in the SEPT9_v2 transcript has been associated with the occurrence of the colorectal cancer. The test uses a real-time polymerase chain reaction (PCR) with a fluorescent hydrolysis probe for the methylation specific detection of the Septin 9 DNA target.

In a large prospective multicenter clinical trial, the Epi proColon test showed sensitivity, specificity, positive and negative predictive values of 68.2%, 78.8%, 2.4% and 99.7% respectively. Because the Epi proColon test is not a confirmatory test for the presence of colorectal cancer, patients with positive Epi proColon test results should be referred for diagnostic colonoscopy. People with negative test results should be advised to continue participating in a colorectal cancer screening program that also includes colonoscopy, fecal tests and/or other recommended screening methods.

Epi proColon may be collected at our outpatient labs in Spectrum Health Grand Rapids Hospitals from open – 2 p.m., Monday thru Friday:

Test information: Epi proColon Septin 9 Methylation Analysis (Epic #LAB3649, Test  #7146)

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