On September 9, 2019 Biodesix, Inc. reported positive clinical data from Oncimmune’s EarlyCDT Lung blood test, which harnesses the power of the immune system to detect evidence of the body’s natural response to cancer (Press release, Biodesix, SEP 9, 2019, View Source [SID1234539380]). The technology can detect cancer on average four years or more before standard clinical diagnosis . Results from the randomized controlled study of 12,209 people at high risk of developing cancer, Early detection of Cancer of the Lung Scotland (ECLS), were presented today at the International Association for the Study of Lung Cancer’s (IASLC) 2019 World Conference on Lung Cancer in Barcelona. In June, Biodesix announced acquisition of Oncimmune and the EarlyCDT Lung test in the United States.

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Prof. Frank Sullivan, Professor of Primary Care Medicine at the University of St. Andrews and Chief Investigator for the ECLS trial, noted the global significance of a blood test, followed by CT scans, to increase the number of patients diagnosed at an earlier stage of disease, when surgery is still possible and prospects for survival are higher. This early diagnosis is especially important in the case of lung cancer because approximately 85 percent of patients are diagnosed with the disease at a late stage, when the cancer has spread to other parts of the body and the chances of survival are low.

Biodesix CEO David Brunel

"This represents a significant opportunity to improve the standard of care in screening for lung cancer. Current screening programs in the United States have seen very slow adoption rates, with only two percent of the eligible eight million U.S. high risk individuals undergoing screening in 2016. The EarlyCDT Lung test is a blood test that can be administered in primary care and used to direct at-risk patients into further investigation with imaging, thereby increasing the proportion of lung cancers diagnosed in early stages. We look forward to continuing our work with Oncimmune to extend the utility of the EarlyCDT Lung test in the U.S. to include lung cancer screening."

In addition to its potential in lung cancer screening, the EarlyCDT Lung test also helps physicians to determine if a pulmonary nodule is potentially cancerous, helping physicians manage nodule patients. The Biodesix Nodify XL2 test, is used to help physicians rule-out malignancy in low-to-moderate risk incidental lung nodules. Biodesix will offer complementary tests that help empower physicians to stratify patients into distinct nodule management pathways.