- Not for diagnostic use in the USA. -
Septin9 test Epi proColon: patient brochure for download
 PDF File (240 kB)
To find out where to get the test please click here
Why is colorectal cancer screening important?
Approximately 210.000 individuals die from colorectal cancer in Europe every year, making colorectal cancer second only to lung cancer in the number of cancer-related deaths. Colorectal cancer is a disease with a 90% cure rate when detected at an early stage. For that reason, regular colorectal cancer screening should be an inherent part of health care, beginning at the age of 50.
Which methods are offered for the early detection of colorectal cancer?
Many countries have screening programs which are paid for under private and public health care schemes.
In Germany, for instance, screening guidelines recommend patients undergo a test for occult blood in stool once a year beginning at age 50. From the age of 55 a colonoscopy is recommended that should be repeated once after ten years. Patients not willing or able to undergo colonoscopy should continue FOBT testing every other year. 1 Similar guidelines apply in other countries including the U.S. Both, colonoscopy and FOBT are proven to be effective in the fight against colorectal cancer. Unfortunately, only a minority of the target population participates in regular colorectal cancer screening because it is perceived to be unpleasant and laborious. We believe our Septin9 test Epi proColon provides a viable alternative that makes colorectal cancer screening acceptable to a wider audience.
What is the Septin9 test Epi proColon?
The Septin9 test Epi proColon is a blood-based test that can be performed as a first step in early detection of colorectal cancer. The assay is able to detect a substance, or “biomarker” in blood plasma that is specific to colorectal cancer. For this purpose the doctor takes a blood draw which is sent to a diagnostic laboratory for analysis. After approximately one week, the doctor receives the result. If the biomarker is detected in the sample, there is an increased likelihood of having colorectal cancer. It is recommended that patients with a positive Septin9 result undergo a colonoscopy to confirm the diagnosis or as a first step in therapeutic treatment.
How does the test work?
Even at the earliest stages, colorectal tumors shed genetic material or DNA into blood. The Septin9 test is able to detect a colorectal cancer-specific change in our genetic information, called mSEPT9. A positive test result indicates that there is an increased likelihood for the presence of colorectal cancer. In this case the doctor will strongly recommend a colonoscopy to confirm the diagnosis.
What are the advantages of the Septin9 test Epi proColon test over other methods for colorectal cancer early detection?
The test is easy and quick to use and thus is comfortable for both, you as a patient and also your family doctor. All it takes for you as a patient is giving a blood sample in your physician’s office as part of your regular check-up. The sample will then be shipped to a local or regional diagnostic laboratory where it will be tested. The result is provided to your doctor who can discuss it with you within a few days.
How can I get tested for Septin9?
The Septin9 test Epi proColon is prescribed by a doctor. It can be prescribed as a stand-alone test or as a part of your regular check-up. Your doctor will order a blood draw. Please ask your family doctor, gastroenterologist, urologist or gynaecologist for the Septin9 test.
Do I have to prepare before taking the test (e.g. a special diet)?
No. There are no nutritional recommendations and also no bowel preparation required for the test. The blood draw can be taken by your doctor at any time.
How long do I have to wait for the results?
Your results will be sent to your doctor, usually within five business days from the date of receipt of the blood sample. Your doctor will discuss the result with you and depending on the result decide about next steps.
If I tested positive for Septin9, does that mean that I have colorectal cancer?
No, not necessarily. Not necessarily. Although a positive result means that you have a high risk of having colorectal cancer, as with many other diagnostic tests, a false positive result can occur. That is why your doctor will recommend that you receive a follow-up colonoscopy for definitive diagnosis. Please follow that recommendation.
If I tested negative can I be confident that I do not have colorectal cancer?
No diagnostic method is perfect and of course, there is a risk of false negative results. This also applies to the Septin9 test. Colorectal cancer arises spontaneously and develops over a period of 10 to 15 years. The most effective cancer prevention is the regular participation in a screening program, independent of the method used.
Does the test replace a colonoscopy?
No. It is the current belief of Epigenomics that the Septin9 test should provide a convenient alternative to other non-invasive screening tests for colorectal cancer early detection.
Is the cost of the test covered by my health insurance?
Currently, the Septin9 test is offered only as a self-pay service. If you are privately insured, your health insurance may reimburse the test. Epigenomics is actively working with gastroenterology and health economics opinion leaders to advocate for coverage of the test under public health care schemes.
1 Source: Information on cancer early detection of the Compulsory Health Insurances (GKV), Stand: July 1st, 2008
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