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One Simple Blood Test Could Save Your Life


ColoMarker® provides patients and physicians a simple, accurate blood testing option to detect colorectal cancer.

The discovery and development of a new revolutionary biomarker, CA11-19™, can provide patients and physicians with an easier method to detect colorectal cancer.  This unique biomarker is measured by a simple blood test called the ColoMarker® test.  Based on pre-clinical IRB studies, the ColoMarker® test has shown promising results in detecting colorectal cancer in the early stages of the disease where it is most treatable.

CE mark

 

ColoMarker

Colonoscopy

In the realm of life-saving tests, colonoscopies have proven their value in the fight to detect the presence of colorectal cancer. Yet, the cost, unpleasantness and discomfort caused by the test leads too many patients to avoid the procedure. In fact, only 50% of patients who should be screened have actually had a colonoscopy.

Whether avoiding the test because of a reluctance to experience discomfort, an unwillingness to take the time, or out of fear, this decision can cost a patient’s life. If detected at Stage I, colorectal cancer has a 90% five-year survival rate. By Stage II, the five-year rate drops to 60% and continues to fall to 10% at Stage IV. A colonoscopy is a valuable tool in detecting early stages of colorectal cancers, but it can’t work if the patient avoids testing.

Clearly a cost-effective alternative, such as a blood test, would be complimentary and perhaps even a replacement to colonoscopy.

EDP Biotech, a US-based medical company, asked this question and dove into extensive research to find a solution.

ColoMarker®: A potential option to Aid in Diagnosis

EDP Biotech’s research into cancer biomarkers identified a protein biomarker shown to exist in elevated levels in colorectal cancer patients. The identification of this biomarker, known as CA11-19™, was the key to developing ColoMarker®, an aid in diagnosis to help physicians identify potential candidates for colonoscopies.

ColoMarker® is a blood test requiring no advance preparation by the patient such as fasting or colon cleansing. ColoMarker® can be added easily to the panel of tests routinely performed on the patient’s blood as part of the patient’s annual physical.

The results are as simple as the test itself. ColoMarker® would return with one of two possible results: normal or elevated. The result can help physicians identify patients who would benefit from additional diagnostics, including colonoscopies.

The ColoMarker® Q&A

How would ColoMarker® work?

ColoMarker® detects a level of CA11-19™ antigen, a specific protein molecule found in the blood stream. While everyone produces this protein, elevated levels in the blood stream suggest the presence of pre-cancerous polyps or colon cancer. Research studies have shown ColoMarker® may be a diagnostic aid in detection of colorectal cancer in the early stages (I, II, III) of the disease, while it is most treatable.

How would ColoMarker® be performed?

ColoMarker® could be ordered by a physician. Blood is drawn and can be taken as part of routine blood work.

What would ColoMarker® results mean?

ColoMarker® has a normal cutoff of 6.4 units/mL.  If a patient receives a 6.4 unit or less result, the level of CA11-19™ antigen found in the blood is within the normal range. An elevated 6.5+ result suggests, but would not necessarily mean the patient has pre-cancerous polyps or colorectal cancer. An elevated level may represent other non-cancerous conditions.  The physician would interpret these results within the context of the patient’s overall health and decide if further testing is necessary. ColoMarker® is only an aid in diagnosis that must be used in conjunction with other tests and other physical symptoms to help physicians diagnose, develop or revise a treatment plan.

Are there any restrictions on preparations for ColoMarker®?

No, the patient does not have to refrain from food, liquids or medications prior to having blood drawn for this test. For this test the colon would not need to be emptied or cleaned by drinking clear fluids and taking laxatives or enemas prior to testing.  Neither smoking nor pregnancy will affect the test.

Are there any risks related to ColoMarker®?

ColoMarker® requires a blood sample drawn from a vein in the patient’s arm. When having blood drawn possible risks may include mild to moderate pain, a prick or stinging sensation when the needle is inserted and bruising and/or swelling at the puncture site. In rare cases infection, blood accumulating under the skin, fainting or feeling light-headed and excessive bleeding could occur.

Comparisons and Results

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Colorectal Diagnostic Tests

Comparison to CEA

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