A blood test for colon cancer. It sounds too good to be true but it may become a reality if EDP Biotech Corporation has its way.

Medical researchers at the privately backed biomedical company in Knoxville, Tenn. may have finally cracked a medical code that has taken decades and billions of dollars. They have developed a technology for a simple blood test to detect early-stage colon cancer.

Following the success of its pre-clinical trials for the ColoMarker™ assay, EDP has filed a patent on the biomarker, CA11-19, and all aspects of its use. Via an inexpensive blood test, ColoMarker™ will detect colon cancer in its earliest, most curable stages, once the test receives FDA approval, the company promises. In pre-clinical trials, ColoMarker™ successfully detected the early stages (I, II, and III) of colon cancer. In tests of 2,370 blood samples, ColoMarker™ showed an accuracy rate of >99% for detecting colon cancer in these early stages.

The small protein biomarker detects tiny traces of a substance in the blood that the tumor gives off in its first phases of development.

"What we are looking at is a small protein that is secreted by the cancers as soon as they appear and it enables us to detect things much, much sooner," said Kevin Jones, Ph.D., EDP's chief scientific officer. "With colon cancer, the key to survivability is to capture the cancer as early as you possibly can."

Unfortunately, that wisdom is more honored in the breach than the observance. "Typically of the 150,000 Americans who are diagnosed with colon cancer every year, 55,000 will die. The reason is that colon cancer is not caught earlier," Jones told DOTmed News. There is greater than a 90% chance of survival if the cancer is caught in stage I and less than 10% if caught in stage IV.

If the company's test is approved, mass colon cancer screening may become a reality. The test is designed to cast a wide net for this very reason.

"Our aim with price point for this test is about $30 dollars--a simple blood test. We want to turn it into an adjuvant or add-on to colonoscopy," he said.

The EDP blood test results, instead of "positive" or "negative," might indicate "negative" or "not negative."

" 'Not negative' means you need to go for further screening. We want to try and capture everyone who would be at risk.... When you look at the seriousness and treatability of the disease, we wanted to make sure that every cancer gets caught and that is why it is a very sensitive screener."

Other Testing Methods

The test would be better than the current fecal occult test that looks for blood traces.

"With fecal occult blood what you are looking for is blood that comes out of a part of the colon that has started to bleed. Basically the cancer got so big the cells have ruptured and you have started to get bleeding from the colon so you are looking at something which is quite well developed," Jones said.

Colonoscopy, of course, is the gold standard test but invasive enough that patients put it off.

"Colonoscopy is a great test. I would never criticize colonoscopy because it is a superb test. The problem is that 82% of Americans who need to be screened are not screened," he said.

Fewer than 20% of Americans over 50 who should be screened for colon cancer actually are, resulting in 135 needless deaths in the U.S. every day. If EDP's test is approved and widely used, that number may go down dramatically. While recent data show an improvement in early screening (DM 10947), clearly much work is yet to be done in combating the nation's second-leading cancer killer (after lung cancer).

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