The United States Food and Drug Administration (FDA) has approved Epi proColon®, a test that screens for colorectal cancer from a simple blood draw. The approval specifies that EPI proColon is only indicated for individuals at an average risk of developing colorectal cancer who choose not to undergo other colorectal cancer screening methods specified in approved screening guidelines.1
Colorectal cancer is the second leading cause of cancer-related deaths in the United States. Effective screening methods for early detection and/or prevention of colorectal cancer that are currently available have the potential to drastically reduce the rate of deaths from this disease, and screening guidelines for colorectal cancer have been established for the population in the US. However, only approximately one-third of the population eligible for screening will actually follow through on a screening procedure. Reasons for this low rate of screening compliance, despite its effectiveness, are thought to include the invasive nature, time commitments, dietary restrictions, and potential side effects associated with available screening methods at present. Therefore, development of an effective screening method for colorectal cancer that minimizes these perceived patient barriers and is considered easy, fast, and non-invasive, may increase the rate of screening compliance in the population. Healthcare providers and U.S medical guideline organizations aim to ultimately achieve an 80% compliance rate in the U.S. for colorectal cancer screening.
The Epi proColon is the only screening test that is based on a blood sample. Importantly, this blood sample can be drawn during a routine healthcare provider visit and requires no dietary or medication restrictions or alterations. The blood sample is analyzed in the laboratory to determine if DNA from cancer cells can be found circulating in a patient’s blood. Patients whose results are positive for colorectal cancer on the EPI proColon test are then referred to undergo a colonoscopy to validate findings.
FDA approval of the EPI proColon was based on results from clinical trials that determined its safety and effectiveness in identifying colorectal cancer. One multi-center study, the PIVOTAL trial, was conducted using blood samples from patients in another large study, referred to as the PRESEPT (Prospective Evaluation of Septin9 Performance in CRC Screening) trial. The PRESEPT trial included over 6,000 patients who were between the ages of 50-85 years, and of average risk of developing colorectal cancer. All patients were undergoing a screening colonoscopy. Blood samples for the EPI proColon test were obtained from the patients prior to their colonoscopy, and results from the EPI proColon test were compared to results of the screening colonoscopy.2
- Overall, the EPI proColon test correctly identified the presence of 68% of all colorectal cancers.
- Results from the EPI proColon test came back positive for colorectal cancer in 21% of patients who ultimately did not have colorectal cancer (false-positive).
- EPI proColon testing detected colorectal cancer at all stages of the disease.
A second large trial further evaluating the effectiveness of EPI proColon was conducted to directly compare results from the EPI proColon test, to the stool-based fecal immunochemical test (FIT). The FIT test is a guideline-approved, non-invasive screening method for colorectal cancer, in which a sample of stool is analyzed to detect for the presence of colorectal cancer.
This trial included approximately 300 patients who had an average risk of developing colorectal cancer and were between the ages of 50 and 85 years. All patients underwent both EPI proColon testing and FIT testing, as well as a colonoscopy.2
- Correct identification of colorectal cancer was 72.2% for the EPI proColon test, compared with 68% for the FIT test.
- False-positive rates were approximately 20% for the EPI proColon test, and approximately 3% for the FIT test.
The approval of EPI proColon represents a novel screening method for colorectal cancer that may potentially increase the compliance rate of screening for this deadly disease.
- Epigenomics receives FDA approval for EPI proColon. Available at: https://www.epigenomics.com/en/news-investors/news-media/press-releases/latest-news/article/epigenomics-erhaelt-fda-zulassung-fuer-epi-procolonR.html. Accessed April 20, 2016.
- United States Food and Drug Administration. The Epi proColon® test product summary and briefing packet. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/UCM390234.pdf. Accessed April 20, 2016.
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