Novigenix Reports Interim European Validation Data on its New NGS-based Whole Blood RNA Signature for detection of Advanced Colorectal Adenomas

LAUSANNE, SWITZERLAND –  Novigenix SA, a leading Immuno-Transcriptomics company that develops and commercializes solutions for early cancer detection and precision medicine, today announced presentation of its interim European validation data for its whole blood RNA signature for early detection of pre-cancerous colorectal cancer legions (Advanced Colorectal Adenomas). The data is presented at the European Society for Medical Oncology (ESMO) GI Congress (28 June – 1 July 2023 | Barcelona, Spain).

Immune cells play a key role in cancer progression and their response to the pre-cancerous legions can promote or prevent tumor growth. The sensitivity of immune cells to onset of tumor genesis may be used to increase the diagnostic power of tests for the early detection of cancer. Predictive signatures identified using Novigenix’s proprietary LITOseek platform, integrating Machine Learning (ML) methods into a feature reduction ranking system, recently demonstrated high performance detection of Advanced Colorectal Adenomas in a discovery and training cohort with a sensitivity of 71% at specificity of 94% (ref: Journal of Clinical Oncology, Vol. 41, Issue 4 suppl). The aim of the current study was to test the performance of the biomarker signature on an independent European cohort. Results from this interim analysis indicate a specificity in the range of 90-85% with sensitivity in the range of 42-54%.

“These are very encouraging data on a whole-blood RNA signature as biomarker for detection of Advanced Colorectal Adenomas” said Prof. Dr. Sabine Tejpar, Gastrointestinal Cancer Specialist at the Katholieke Universiteit Leuven, Leuven, Belgium. “The interim validation data on independent cohort shows promise for a whole blood assay in CRC screening”.

“We have previously developed and launched a first-in-class transcriptomic PBMC test Colox^® on the Swiss market for the early detection of Colorectal Cancer and Advanced Colorectal Adenomas.” said Dr. Brian Hashemi, CEO and Chairman of Novigenix. “This newly developed NGS-based RNA signature in stabilized whole blood removes the pre-analytic complexity of handling PBMC and demonstrates good detection power with streamlined sample collection and processing that is suitable for adopted in routine medical practice for CRC screening.”

Further studies are currently underway for validation of the test in additional independent patient cohorts.

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 to cancer and its immune responses to therapeutic modalities. 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 potentially predict onset and progression of disease. The Company has established a valuable multi-ethnical biobank and database of over 3,000 patients 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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