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Colox
Early detection
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Colox
COLOX is being developed as a highly accurate non-invasive colorectal cancer screening test that is easy to use in clinical practice and allows systematic screening of the millions of people at risk worldwide. It does not require hospitalization, its results are accurate and reproducible, and targets only patients referred for colonoscopy. Based on its unique features, COLOX has the potential to become “the” pre-colonoscopy gold standard.
Unlike present solutions, COLOX results are obtained from peripheral blood samples. This greatly facilitates adoption of the test when compared to multiple and uncomfortable stool collection, changes in diet and overall disturbance associated with fecal occult blood testing or genomic stool testing. With the use of COLOX, colonoscopy will shift from a screening to an interventional procedure.
Early detection of colon cancer
With 5% of the population concerned, colorectal cancer (CRC) is one of the most prevalent cancers in the developed world. Broad population screening presents an attractive strategy to mitigate the important public health issued surrounding CRC. However, given the size of the population at risk, the characteristics of an optimal screening test for average-risk, asymptomatic individuals needs to meet several important conditions: it needs to be highly sensitive and specific, non-invasive, cost effective, and scalable, i.e. easy to implement across a large population. Current routine screening tests include fecal occult blood testing, sigmoidoscopy and colonoscopy. But despite promising new technologies such as Computer Tomography Imaging, today’s screening tests lack the required sensitivity and specificity and in many instances fail to detect CRC while present.
With the aim to discover and develop a non-invasive test for CRC, Diagnoplex and its academic collaborators, the gastroenterology and visceral surgery departments at the University Hospital of Lausanne, Switzerland, identified a specific gene expression CRC signature in peripheral blood. This signature was subsequently tested in a pilot clinical study with 140 patients. The test involves the separation of Peripheral Blood Mononuclear Cells (PBMCs), RNA extraction and a robust assay of simultaneous quantification of transcripts by single-channel quantitative multiplex reverse transcriptase-polymerase chain reaction (scqmRT-PCR) method. This approach allows the same quantification of copy number as can be obtained with real-time PCR. But scqmRT-PCR goes further. In the patient blood samples that we analyzed, we were able to quantify up to 52 genes simultaneously. Four groups of well-characterized patient were included: controls, polyps, (adeno)carcinoma and inflammatory bowel disease. Statistical analysis led to a specific and relevant signature of 24 genes, which include markers for angiogenesis, tissues invasion, and immune response. Diagnoplex and its partners are currently planning a study in some 1000 patients, and the finalization of statistical tools needed for prospective data processing.
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