PCR-Based CRC Early Detection Stool Test Fills Important Gap Between FIT and Colonoscopy

Colorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable, with early detection providing survival rates above 90%. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC. One of the main reasons for the large number of late diagnoses is the mostly symptom-free development of CRC. Symptoms are rare in early stages, which is why patients often do not see a doctor until the disease has already progressed. The usual screening procedures are two colonoscopies at a 10-year interval or fecal immunochemical tests (FITs) performed annually or biannually, depending on the country. However, both services involve disadvantages: even though colonoscopies are very precise, they are rarely used, mainly due to the unpleasant procedure and lengthy intestinal cleansing. While occult blood tests are more widely accepted, they can only provide indirect evidence of disease and often only in later, bleeding stages.

Now, a simple-to-administer test detects CRC with a sensitivity and specificity nearly as high as the invasive colonoscopy. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the FIT. It is designed to detect tumor DNA and CRC cases in their earliest stages. Mainz Biomed N.V.’s (Mainz, Germany) ColoAlert is a highly efficacious, and easy-to-use detection test for CRC that detects bleeding and non-bleeding tumors through tumor DNA analysis and thus offers a better early detection than fecal occult blood (FOB) tests. The ColoAlert stool test was developed to detect changes in the bowel as accurately and early as possible.

Colorectal cancer originates from the genetic mutation of intestinal cells. These are continuously excreted through the stool and can be examined for tumor DNA using modern genetic diagnostic methods. ColoAlert analyses samples for the following tumor makers: KRAS-mutation, BRAF-mutation, total amount of human DNA, and occult blood. These tumor markers can be associated with the occurrence of cancer. By analyzing tumor DNA, ColoAlert detects 85% of CRC cases and often in very early stages of the disease.

Clinical studies also confirm the advantages of tumor DNA analysis. In a multi-centric study, a total of 566 patients were examined simultaneously using the occult blood test, M2-PK test and ColoAlert. All methods were also compared with the colonoscopy. With a sensitivity of 85% and a specificity of 92%, ColoAlert showed the most accurate test results among the non-invasive screening methods. ColoAlert is the only CE-IVD DNA based test available in Europe and fills the important gap between FIT and colonoscopy.

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