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Intended Use

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 sequence in the promoter region of the SEPT9_v2 transcript has been associated with the occurrence of colorectal cancer (CRC). 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.

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.

Contraindications

      • The Epi proColon® test is not intended to replace colorectal cancer screening tests that are recommended by appropriate guidelines (e.g., 2008 USPSTF guidelines) such as colonoscopy, sigmoidoscopy and high sensitivity fecal occult blood testing.
      • The Epi proColon® test is not intended for patients who are willing and able to undergo routine colorectal cancer screening tests that are recommended by appropriate guidelines.
      • The Epi proColon® test is not intended for patients defined as having elevated risk for developing CRC based on previous history of colorectal polyps, CRC or related cancers, inflammatory bowel disease (IBD), chronic ulcerative colitis (CUC), Crohn’s disease, familial adenomatous polyposis (FAP). Persons at higher risk also include those with a family history of CRC, particularly with two or more first degree relatives with CRC, or one or more first degree relative(s) less than 50 years of age with CRC.
      • The Epi proColon® test has not been evaluated in patients who have been diagnosed with a relevant familial (hereditary) cancer syndrome, such as non‐polyposis colorectal cancer (HNPCC or Lynch Syndrome), Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner’s syndrome, Turcot’s (or Crail’s) syndrome, Cowden’s syndrome, Juvenile Polyposis, Cronkhite-Canada syndrome, Neurofibromatosis, or Familial Hyperplastic Polyposis, or in patients with anorectal bleeding, hematochezia, or with known iron deficiency anemia.

Warnings, Limitations and Precautions

      • The Epi proColon® test demonstrated inferiority to a fecal test (OC-Auto® Polymedco, Inc.) for specificity, indicating that the Epi proColon® test exhibited a higher rate of false positive results compared to the FIT test. The Epi proColon® demonstrated non-inferiority to a fecal test for sensitivity.
      • A positive Epi proColon® test result is not confirmatory evidence for CRC. Patients with a positive Epi proColon® test result should be referred for diagnostic colonoscopy.
      • A negative Epi proColon® test result does not guarantee absence of cancer. Patients with a negative Epi proColon® test result should be advised to continue participating in a recommended CRC screening program according to screening guidelines.
      • Screening with Epi proColon® in subsequent years following a negative test result should be offered only to patients who after counseling by their healthcare provider, again decline CRC screening methods according to appropriate guidelines. The screening interval for this follow-up has not been established.
      • The performance of Epi proColon® has been established in cross‐sectional (i.e., single point in time) studies. Programmatic performance of Epi proColon® (i.e., benefits and risks with repeated testing over an established period of time) has not been studied. Performance has not been evaluated for patients who have been previously tested with Epi proColon®. Non‐inferiority of Epi proColon® programmatic sensitivity as compared to other recommended screening methods for CRC has not been established.
      • The rate of false positive Epi proColon® results increases with age. Test results should be interpreted with caution in elderly patients.
      • CRC screening guideline recommendations vary for persons over the age of 75. The decision to screen persons over the age of 75 should be made on an individualized basis in consultation with a healthcare provider.
      • Positive test results have been observed in healthy subjects and in patients diagnosed with chronic gastritis, lung cancer, and in pregnant women.
      • Test results should be interpreted by a healthcare professional. Patients should be advised of the cautions listed in the Epi proColon® Patient Guide.

For more information, please refer the Epi proColon® Instructions for Use/Package Insert (IFU 0008)

Download IFU 0008