Novigenix’s New Early Colon Cancer Detection Blood Test Demonstrates Positive Results

Novigenix SA, a leading Immuno-Transcriptomics company that develops and commercializes solutions for early cancer detection and precision medicine, today announced promising data from a study of a new Immuno-Transcriptomic signature for early detection of colorectal cancer (CRC) in blood. The data were presented at the European Society for Medical Oncology (ESMO) meeting (27^th September -1^st October, Barcelona, Spain).

In the study, peripheral blood mononuclear cells (PBMC) Immuno-Transcriptome profiles were generated by RNA sequencing from 282 subjects (78 CRC, 65 advanced adenomas, 39 other cancers and 100 subjects with no colorectal lesions). A final signature of 524 genes showed high clinical performance, with an AUC of 90%, 88% specificity and 83% sensitivity for CRC detection. In the first half 2019, Novigenix launched a prospective colon cancer clinical validation trial (PREVASCO), which is expected to enroll over 1,600 subjects from six major cancer centers in Europe. Samples from this study will be used for the final validation of the newly developed non-invasive colon cancer test based Novigenix’s LITOseek platform.

“The performance data of the newly discovered immune-transcriptomic signature for the detection of early CRC in blood are very encouraging,” said Dr. Jan Groen, CEO of Novigenix. “Our partner Biolizard is developing an AI-based bioinformatics algorithm for this test on our LITOseek platform, which we believe could improve on the already promising performance data of the test seen in studies to date.”

Colon cancer is the second deadliest cancer in the world, with over 1.8 million newly diagnosed cases per year. European studies have shown compliance rates as low as 10% for colorectal cancer screening using colonoscopy, the standard of care. Early cancer detection will significantly increase the overall survival rate, but this can only be achieved with sensitive non-invasive liquid biopsy tests. Immune cells play a key role in cancer progression and their response to the tumor. Novigenix’s Colox^® was the first commercially available Immuno-Transcriptomic blood based test, which has been used to help screen more than 4,000 individuals. Post-market validation of Colox has shown an enrichment of 60% of advanced adenoma compared to a CRC average risk population. The negative predictive value of the test was estimated to 99.8%.

About LITOseek

Novigenix’s Blood Immuno-Transcriptomic sequence platform, LITOseek, analyzes the gene expression modifications (mRNA signatures) induced by the host response to various triggers, such as the onset of cancer. Disease specific algorithms are developed combining the mRNA signature with clinical and medical parameters. The combination of mathematical models with machine learning and collection of new data enables the continuous improvement of the predictive and adaptive algorithms.

About Novigenix

Novigenix is committed to providing a new understanding of the human host response against cancer. The Company was founded on the vision that Immuno-Transcriptomics will bring unprecedented advances in diagnosing and treating cancer patients leading to significant improvement in healthcare. Novigenix’s unique Immuno-Transcriptomics technology enables an accelerated identification of disease specific mRNA signatures of circulating immune cells, which combined with machine learning and predictive algorithms, can predict onset and progression of disease. The Company has established a valuable multi-ethnical biobank and database of over 1,400 patients at risk of colorectal cancer (CRC) and has launched its first blood-based molecular diagnostic product, Colox^®, for the early detection of colon cancer. For more information visit www.novigenix.com.

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