Prospective Clinical Study
BARD1 plans to conduct a Prospective Clinical Study to demonstrate the safety and performance of the BARD1 Test compared to the current gold standard CT Scan in 1000 high-risk individuals. Importantly, the clinical validation study will prove the effectiveness of the test for early detection of lung cancer in asymptomatic individuals, and enable marketing as a Laboratory Developed Test (LDT) or approval as In Vitro Diagnostic (IVD) test in Europe, the USA and other key marketplaces. The goal of the study is to verify that the BARD1 Lung Cancer Test achieves a lung cancer detection rate of greater than 90% and a false positive rate of less than 10%. The planned prospective clinical study is expected to commence in 2H17.