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ColoAlert - The Evidence

“By detecting tumour DNA, ColoAlert® effectively minimises the analytical gap between colonoscopy and other stool tests.“

Prof. Dr. Dr. M. Dollinger; Head of ColoAlert study;

Chief Physician Landshut Hospital

An independent multi-centre study investigated the sensitivity and specificity of three stool tests.A total of 566 patients used a blood-in-stool test as well as the M2-PK test and ColoAlert®. These three non-invasive tests were also compared to the existing gold standard, the colonoscopy. The blood-in-stool test scored with a very good

specificity of 97 %, but its sensitivity was by far the lowest. In the case of the M2-PK test, the opposite was true. Although the combination of both tests increased the sensitivity to 92 %, it remained very unspecific at 59 %. ColoAlert® achieved the most accurate predictive value of the non-invasive methods in this study: In addition to a high sensitivity of 85 %, the minimum specificity of 90 % for the detection of colorectal cancer recommended by oncology guidelines easily could be exceeded.

Several other clinical studies have also shown the great benefits of genetic diagnostics in colorectal cancer screening. These serve as further proof of the high clinical significance of tests such as ColoAlert®, which are based on a combination of the evidence of tumour DNA and blood-in-stool.

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