Universal DX Presents Data at EACR Virtual Congress; Top-Scoring Poster Shows Accurate Detection of Colorectal Advanced Adenomas
New results from the OMICS study, the company's prospective, international, multi-center study, show Universal DX's blood test can detect colorectal advanced adenomas at 55% sensitivity and 90% specificity, which exceeds currently available non-invasive tests for colorectal cancer screening 80% of sporadic colorectal cancers arise from pre-malignant advanced adenomas, making early detection critical to saving lives
CAMBRIDGE, Mass., Jun 10, 2021 /PRNewswire/ -- Universal Diagnostics (UDX), a bioinformatics and multi-omics company on a mission to transform cancer into a curable disease, announced at the European Association of Cancer Research (EACR) 2021 virtual conference the results of an international multicenter observational cohort study: The detection of colorectal advanced adenomas (AAs) with 55% sensitivity and 90% specificity using single targeted sequencing analysis of methylation markers, advanced computational biology and machine learning algorithms.
Last week, the company presented similarly promising data at the 2021 ASCO Annual Meeting: CRC detection at 92% sensitivity and 97% specificity.
Setting Universal DX apart in the exciting and growing liquid biopsy market is its focus on identifying cancer in its earliest, even pre-cancerous, stages. When compared to currently available and FDA-approved blood and stool-based tests, Universal DX's blood test demonstrated significantly higher accuracy for detecting advanced adenomas.
"We have demonstrated that we can identify cancer in its earliest stages with 90+% sensitivity, which is a critical first step to transforming cancer into a curable disease," said Christian Hense, managing director at Universal DX. "But where we really want to get to is to prevent colorectal cancer altogether. With the findings presented at EACR, we are on the path to a minimally-invasive blood test that can identify cancer in its pre-cancerous forms, enabling us to prevent what is currently the 3rd most common type of cancer in men and 2nd in women worldwide. This test will reduce incidence of colorectal cancer."
OMICS Study Conclusions:
- ctDNA methylation sequencing data analysis using read-wise scoring approach combined with a machine-learning algorithm is highly diagnostic for advanced colonic adenomas (55% sensitivity at 90% specificity). For high-grade dysplasia and carcinoma in situ, which are the advanced adenoma most likely to develop into colorectal cancer, sensitivity was 63%.
- This method could serve as the basis for a highly accurate and minimally-invasive blood-based screening test with significant implications for early detection and cancer prevention.
- Prospective clinical trials are underway to validate the performance of this novel biomarker panel for advanced adenoma detection in representative screening cohorts.
Universal DX leverages proprietary, state-of-the-art computational biology tools combined with targeted next generation sequencing (NGS) assay platform for highly sensitive cancer signal scoring of cell-free DNA regions linked to cancer of interest. The company is developing "Signal-X", a platform to detect multiple types of cancer; its first product, "Signal-C", detects early-stage colorectal cancer and adenomatous polyps.
Hense continued: "At Universal DX, we understand the growing need to have a non-invasive screening option for colorectal cancer: 30% of adults are not up to date on their colon cancer screening, while the rate of CRC has more than doubled among adults younger than 50. We don't just want to just detect cancer, we want to prevent it. These data reveal that future is within reach."
The company presented virtually at EACR, on June 9. More information here.
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.
Media contact:
Kristin Faulder (on behalf of Universal DX)
(568) 419.4652
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