Clinical Validation

BARD1 plans to conduct a Clinical Study to demonstrate the clinical performance of BARD1-Lung compared to the current gold standard CT Scan in high-risk asymptomatic individuals. The goal of the study will be to verify that BARD1-Lung achieves an acceptable sensitivity and low false positive rate for early detection of lung cancer.

Importantly, the clinical study will evaluate the accuracy of BARD1-Lung for early detection of lung cancer to support future marketing firstly as a Laboratory Developed Test (LDT) and later as an In Vitro Diagnostic (IVD) in the USA, Australia and other key marketplaces.