BSI’S LUNG CANCER TEST HAS BEEN VALIDATED IN TWO INDEPENDENT CLINICAL TRIALS
Discovery phase
During the first phase (discovery), we performed a cross-sectional observational study in one center, at the university of Debrecen. The cohort contained 153 lung cancer, 107 colon cancer, 106 breast cancer, 152 prostate cancer, and 26 ovarian cancer subjects and 320 apparently healthy age- and sex-matched controls.
Clinical qualification, validation, and regulatory phase
In the second phase, or the clinical qualification, validation, and regulatory approval phase, we ran a four-center cross-sectional observational study on COPD/non-COPD controls and symptomatic lung cancer patients with or without COPD. The biobank of the collected samples was audited by an independent clinical trial auditor. We collected 908 samples: 425 lung cancer and 483 controls. The samples were matched for sex, BMI, and COPD status, smoking habits and ethnicity. Multivariate index panels were developed by machine learning algorithms and re-tested on the first phase cohorts.
