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Epi proColon®, Septin 9 Gene Methylation Detection
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Information

Methylated Septin 9 is a DNA marker associated with colorectal cancer.

Epi proColon® is a qualitative in vitro diagnostic method for the detection of methylated Septin 9 DNA in EDTA plasma derived from patient whole blood specimens. Methylation of the target DNA sequence in the promoter region of the SEPT9_v2 transcript has been associated with the occurrence of colorectal cancer (CRC).

The Epi proColon® test is indicated to screen adults of either sex, 50 years or older, defined as average risk for CRC, who have been offered and have a history of not completing CRC screening. Tests that are available and recommended in the USPSTF 2008 CRC screening guidelines should be offered and declined prior to offering the Epi proColon® test. Patients with a positive Epi proColon® test result should be referred for diagnostic colonoscopy.

The Epi proColon® test results should be used in combination with physician’s assessment and individual risk factors in guiding patient management.

Methodology
Real-Time Polymerase Chain Reaction
Specimen Required

This test requires 10 mL of plasma (minimum volume 5 mL).
Stability:
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: 28 days

CPT Code(s)
81327