COMPANY:

Universal DX

"Universal DX...announced closure of the Series B which funds the clinical trial for its colorectal cancer screening blood test, Signal-C®, aimed at achieving FDA premarket approval."

"Universal DX...announced a strategic collaboration with Quest Diagnostics ('Quest')...designed to improve colorectal cancer screening in the United States – for which more than 110 million people may be eligible. Under the commercial agreement between UDX and Quest, Quest plans to perform and provide clinical laboratory services to providers and patients in the United States based on UDX's Signal-C, an advanced colorectal cancer screening blood test, assuming premarket approval of the test in the United States."

"Universal Diagnostics...announced the results of a large international multi-cohort case-control study, which demonstrate that cell-free DNA methylation and fragmentation signals combined with machinelearning can be used to detect early-stage colorectal cancer (CRC) with 93% and pre-cancerous advanced adenomas (AA) with 54% sensitivity at 92% specificity."

"Universal Diagnostics (Universal DX)...announced the results of a cohort study that highlights the role fragment size, specifically on chromosome 18, plays in early-stage CRC detection...Study results demonstrate that combining copy number variation (CNV) information with cfDNA fragment size information could serve as a new avenue for early detection of colorectal cancer, with early-stage (I-II) CRC sensitivity of 87.5% at 92% specificity."

"Universal DX is planning for discussions with the US Food and Drug Administration as more positive data for its Signal-C liquid biopsy colorectal cancer early detection test emerges."

"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 an international, observational cohort study which evaluated the effectiveness of utilizing a combination of cell-free DNA (cfDNA) methylation, fragmentation and machine learning to detect early-stage colorectal cancer (CRC)."

"Universal Diagnostics...announced the results of a study evaluating putative methylation markers in biological context of early colorectal cancer (CRC) development...Study results...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...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 Diagnostics (Universal DX)...announced the results of a proof of principle study demonstrating that the analysis of microbiome signatures in plasma can assist in early detection of colorectal cancer (CRC)...This advancement follows the company’s promising early findings that revealed early-stage colorectal cancer detection through analysis of cell-free circulating tumor DNA (ctDNA) methylation, mutation and fragmentation patterns by using targeted sequencing analysis, advanced computational biology and machine learning algorithms to detect colorectal cancer and advanced adenomas."