Universal Diagnostics (UDX), an in-vitro diagnostics company developing minimally-invasive, blood-based solutions for detecting cancer early, announced today promising new data for its investigational blood-based lung cancer test. The data, presented at the IASLC 2020 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC20), held virtually 28th-31st January 2021, used methylation status measurement of the tumour-derived portion from cell-free DNA (cfDNA) in plasma for patient classification. Results of the study show the potential of the test to detect different lung cancer sub-types early, with high sensitivity and specificity, and indicate the potential of using blood-based screening for wider population regardless of the smoking-status of the patient.
"These initial results from our lung cancer test study are promising, particularly for detecting cancer at the early stages. With current methods for lung cancer screening being limited, with the majority of patients being detected too late, we believe there is a significant opportunity to improve outcomes for lung cancer patients using a simple and accurate blood-based test for early detection through mass screening," said Juan Martínez-Barea, Co-Founder and President of Universal Diagnostics. "We will now build on these preliminary results and plan to move forward with test development, including starting clinical sample collection studies and further improving the panel and its performance. Beyond this, the results demonstrate our ability to leverage our technology for other cancer tests. "
In the study (P46.06 – "Cell-Free DNA (cfDNA) Methylation Assay Allows for Early Detection and Identification of Lung Cancer"), plasma samples of 37 lung cancer patients and 71 asymptomatic age, gender and smoking-history matching controls were assessed using UDX’s 10 methylation marker panel. The panel exhibited good lung cancer detection potential, with sensitivity for detecting lung cancer of 73% (27/37) at 90% (64/71) specificity. A total of 82% of adenocarcinoma (9/11), 80% of squamous cell carcinoma (8/10), 73% of small cell lung cancer (8/11) and 40% of other rare lung cancer subtypes (2/5) were correctly identified. Notably, the sensitivity for stage I cancers was 73% (11/15).
About Universal Diagnostics
Universal Diagnostics (UDX) is a Spanish in-vitro diagnostics company developing minimally-invasive, blood-based tests for detecting cancer early when treatment options are more plentiful. The tests rely on proprietary methylation marker panels. A simple blood sample, collected as part of a routine check-up, can be processed at a reference laboratory or hospital using standard equipment and the data uploaded to the UDX cloud for analysis and condition assignment. To date, UDX has raised €20 million in equity financing and a further €5 million in grants and non-dilutive funding. The Company employs a team of 25 professionals.
Further details can be found at http://www.universaldx.com.
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