New Data from Universal DX Demonstrates Effective Detection of Early-stage Colorectal Cancer Using Combination of Methylation, Fragmentation and Machine Learning

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Universal Diagnostics (Universal DX), a bioinformatics and multi-omics firm on a mission to rework most cancers right into a curable illness, as we speak introduced the outcomes of a global, observational cohort research which evaluated the effectiveness of using a mix of cell-free DNA (cfDNA) methylation, fragmentation and machine studying to detect early-stage colorectal most cancers (CRC).

This is the most recent in a collection of findings from Universal DX; as we speak’s information demonstrates the use of methylation and fragmentation traits of cancer-related cfDNA areas, mixed with a machine-learning algorithm is extremely correct for early-stage (I-II) CRCs (92% sensitivity at 94% specificity). These outcomes have been achieved on a prospectively collected affected person pattern set from 4 totally different populations: the U.S., Spain, Germany, and Ukraine.

Universal DX has beforehand proven that non-invasive blood testing can be utilized to detect CRC and pre-cancerous superior adenomas (AA) by each evaluation of cell-free circulating tumor DNA (ctDNA) methylation, fragmentation and microbiome patterns with single focused sequencing evaluation and combining it with superior computational biology and machine studying algorithms. In 2022, the corporate prolonged early-stage colorectal most cancers detection to prognostics and stratification; the flexibility to take action may result in higher outcomes and improved survival charges.

“This research additional validates and reinforces the work we’re doing to develop assessments that detect most cancers in its earliest levels,” mentioned Christian Hense, COO at Universal DX. “With a totally new pattern set, we now have once more demonstrated highly-accurate early-stage CRC detection, additional verifying the robustness of our expertise and use of biomarkers to seek out traces of most cancers in an individual’s blood. At Universal DX, we consider early detection is one of essentially the most highly effective instruments for enhancing survival charges, and are inspired to see these promising outcomes as soon as once more.”

Study outcomes:

Prediction mannequin that utilized a panel of methylation and fragmentation scores originating from cfDNA biomarkers that belong to related most cancers improvement and progression-related pathways accurately labeled 92% (87/95) of CRC sufferers.

Sensitivity per most cancers stage ranged from 91% (21/23) for stage I, 92% (23/25) for stage II, 91% (30/33) for stage III and 93% (13/14) for stage IV.

Fragmentation indicators contributed most to early-stage cancers (I-II), whereas methylation indicators have been extra vital for late stage (III-IV) detection.

Specificity of the mannequin was 94% (199/204), with 97% (28/29) NAA (non-advanced adenoma), 93% (116/125) BEN (benign colonoscopy findings of diverticulosis/diverticulitis, hemmorhoids, hyperplastic/inflammatory polyps) and 94% (47/50) cNEG (colonoscopy damaging) sufferers accurately recognized.

Lesion location, gender, age and nation of origin weren’t considerably correlated to prediction final result.

Universal DX leverages proprietary, state-of-the-art computational biology instruments mixed with a focused subsequent era sequencing assay platform that permits for simultaneous detection of methylation, fragmentation and microbiome indicators for highly-sensitive most cancers sign scoring of cell-free DNA areas linked to most cancers of curiosity.

Hense continued: “Colorectal most cancers is the third most typical most cancers identified within the U.S.; in 2023, The American Cancer Society estimates there will probably be greater than 150,000 new diagnoses of colon and rectal most cancers. This demonstrates the necessity to not solely prioritize screening, however discover instruments that assist us detect most cancers in its earliest types, when there are extra therapy choices obtainable and survival charges are increased.”

Universal DX will current its findings dwell on the ASCO Gastrointestinal Cancers Symposium in San Francisco, CA on January twenty first as poster #201 titled “Use of methylation and fragmentation indicators within the detection of early-stage colorectal most cancers.”

In addition to as we speak’s outcomes, the corporate will probably be presenting findings from further research within the upcoming months.

About Universal Diagnostics

Universal DX is on a mission to rework most cancers right into a curable illness. With its multi-omics + computational biology + machine studying strategy, it’s cracking the code to “true” early most cancers detection, having recognized the particular cfDNA sequence areas that seize most cancers’s earliest sign with +90% accuracy. Its first single-draw blood take a look at, Signal-C, detects colorectal most cancers with excessive sensitivity and specificity, with extraordinary accuracy for earlier levels. The firm’s multi-cancer platform seeks to establish the distinctive DNA sequence areas related to high-burden cancers, resembling pancreatic, liver, lung and abdomen, with excessive sensitivity and tissue-of-origin specificity.

For extra details about the corporate, go to

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