An ally against colon cancer

Novigenix reports validation data on Colox blood test for colorectal cancer

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LAUSANNE, Switzerland—“Physicians today are facing a challenge in convincing average-risk asymptomatic individuals to be screened for colorectal cancer (CRC) due to the invasive nature of colonoscopy and the reluctance of individuals to manipulate stool samples. There is therefore an unmet need for an effective and routine test for asymptomatic average-risk individuals. A blood-based test is highly attractive due to its minimal invasiveness, convenience and high acceptance by individuals at average risk.”
These words, from the Novigenix SA publication of a clinical validation study of Colox in the journal Clinical Cancer Research, explained the need for Colox, a blood test based on a 29-gene host immune response panel in combination with tumor biomarkers for the early detection of CRC. The study, “Development and clinical validation of a blood test based on 29-gene expression for early detection of colorectal cancer,” was conducted across seven institutions in Switzerland.
The study was designed to validate Colox on three independent test sets of patients, who were followed up with colonoscopy to determine the clinical performance of the test (sensitivity and specificity). The data show that Colox has a specificity of 92 percent and a sensitivity of 78 percent for CRC and, respectively, 92 percent and 52 percent for large adenomas. Dr. Gian Dorta of the Department of Gastroenterology and Hepatology at the Centre Hospitalier Universitaire Vaudois was principal investigator.
Colorectal cancer is the second leading cause of cancer mortality in Europe and North America. According to the study, more than 1.4 million patients in the world annually are diagnosed with CRC, and about half of these patients die from the disease. If diagnosed early, “CRC has a good therapeutic response with high survival rates,” but “advanced and metastatic stages of the disease are associated with poor prognosis.” Because the disease can develop from pre-malignant lesions, such as adenomatous polyps, and because there can be a long pre-symptomatic course of the disease, it is critical to screen for CRC in asymptomatic, average-risk individuals, the study said.
“The inconvenience of current methods to detect colorectal cancer results in low adoption and the majority of individuals at risk not being tested,” explained Prof. Curzio Rüegg of the Department of Medicine at University of Fribourg, who was involved in the test’s development. “Colox has all the hallmarks of an effective and convenient test for colorectal cancer that can reliably identify patients for referral to intervention by colonoscopy. In addition, because of its unique combination of host immune response with tumor-derived markers, Colox has the ability to detect precursor lesions of colorectal cancer, making it a promising ally in cancer prevention.”
Offered by Novigenix, a Swiss molecular diagnostics company focused on the commercialization of new blood tests for the early detection of cancer, Colox is a molecular blood test that has been designed to support physicians in case finding of patients with CRC and adenomas for referral to colonoscopy. The test can support the healthcare community to significantly reduce mortality from colorectal cancer through early detection and intervention, the company said. Colox can be ordered by any physician in routine medical practice to identify patients with adenomatous polyps and colorectal cancer.
Colox is based on the analysis of peripheral blood mononuclear cells (PBMCs) isolated from a routine blood sample, according to the company. PBMCs are responsive to growing adenomatous polyps and colorectal carcinomas as part of the host response.
The test measures the combined response of the gene expression profile of 29 biomarkers by real-time PCR in PBMCs and the concentration of two protein tumor markers in plasma. The biomarker measurement data are interpreted by Novigenix’s proprietary algorithm, which generates the Colox test result. This algorithm is based on classifier combinations derived from mathematical analytical methods.
“The publication of our study in Clinical Cancer Research provides important validation of the clinical significance of Colox,” said Brian Hashemi, executive chairman of Novigenix. “As a convenient and accurate blood test, Colox outperforms other commercially available CRC blood tests and has the potential to become truly instrumental in the reduction of cancer mortality through early detection of advanced polyps and colorectal cancer.”

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