CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Universal Diagnostics (Universal DX), a bioinformatics and multi-omics company on a mission to transform cancer into a curable disease, today announced the results of a study evaluating putative methylation markers in biological context of early colorectal cancer (CRC) development.

Universal DX has previously shown that non-invasive blood testing can be used to detect CRC and pre-cancerous advanced adenomas (AA) through both analysis of cell-free circulating tumor DNA (ctDNA) methylation, fragmentation and microbiome patterns with single targeted sequencing analysis and combining it with advanced computational biology and machine learning algorithms.

Today’s news is the latest in a series of findings from Universal DX, extending early-stage colorectal cancer detection to prognostics and stratification, which could lead to better outcomes and improved survival rates.

“This newest study underscores the robustness and validity of our previous results, by adding more biological value to the individual methylation marker regions,” said Christian Hense, COO at Universal DX. “Investigating their impact on gene expression and putting these biomarkers in the context of biological pathways allows for better understanding of the behavior of early cancer. Extending early detection potential of the markers to further prognostics and stratification could lead to improved survival outcomes of the patients as well as potentially serve as interesting new treatment targets in the future. Every step in our research gets us closer to a day where cancer is a curable disease and we can save more lives.”

Study results:

• Differential signal was observed between AA and NAT and CRC and adjacent normal tissue, indicating biological signal change with adenoma progression to cancer.
• Hierarchical clustering identified 3 distinct classes of patients based on methylation levels.
• KEGG pathway analysis revealed that the top pathways involved were axonal guidance, ephrin receptor signaling, epithelial-mesenchymal transition and FGF signaling, all which play a significant role in the context of cancer development and progression.
• Correlation of methylation signal to transcriptomics data from The Cancer Genome Atlas (TCGA) COAD and READ cohorts showed significant correlation to dysregulation of the gene expression, indicating the functional relevance of the gene methylation.
• Targeted methylation sequencing on plasma samples of patients with early stage (I-IIA) colorectal cancer (26 patients from Ukraine and Germany) and age and gender matching colonoscopy-verified controls (from same cohort), showed high individual marker accuracy with AUC > 0.73.
• Kaplan-Meier analysis showed significant correlation to patients’ 5- year survival prediction linked to 3 genes: FGF14 (p=0.025, HR = 1.75), DPY19L2P1 (p=0.012, HR = 1.86), PTPRO (p=0.046, HR = 1.63).

Universal DX leverages proprietary, state-of-the-art computational biology tools combined with a targeted next generation sequencing assay platform that allows for simultaneous detection of methylation, fragmentation and microbiome signals for highly-sensitive cancer signal scoring of cell-free DNA regions linked to cancer of interest.

Hense continued: “CRC is one of the deadliest cancers in the United States. The current methods of biomarker-based tests to screen for CRC are still extremely limited. At Universal DX, we are on a mission to find new and better methods. We know early detection is one of the most powerful tools for improving survival rates, so identifying these markers could be the next step towards earlier – and easier – detection.”

Universal DX will present its findings live at the AACR special conference on Precisions, Prevention, Early Detection, and Interception of Cancer in Austin, TX November 17-19.

About Universal Diagnostics

Universal DX is on a mission to transform cancer into a curable disease. With its multi-omics + computational biology + machine learning approach, it is cracking the code to “true” early cancer detection, having identified the specific cfDNA sequence regions that capture cancer’s earliest signal with +90% accuracy. Its first single-draw blood test, Signal-C, accurately detects colorectal cancer with a sensitivity rate of 92% and specificity rate of 97%, with extraordinary accuracy for earlier stages (89%/97%). The company’s multi-cancer platform seeks to identify the unique DNA sequence regions associated with high-burden cancers, such as pancreatic, liver and stomach, with high sensitivity and tissue-of-origin specificity.

For more information about the company, visit https://www.universaldx.com/.

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