Analytical Validation

Proof of Concept (POC) Study

Proof of Concept (POC) Studies have been completed validating BARD1 antibodies as biomarkers for detection of lung cancer and demonstrating the high sensitivity and specificity of the prototype BARD1 Test.

The initial POC study was conducted by Dr Irminger-Finger and her team at UNIGE using a routine ‘ELISA’ laboratory assay method to screen more than 200 lung cancer and healthy individuals for anti-BARD1 antibodies. By screening a peptide library of possible BARD1 antigens for capturing anti-BARD1 antibodies in the blood of lung cancer patients, the team defined an “optimal” combination of BARD1 peptide antigens as the BARD1 Lung Cancer Test which accurately detected the presence of cancer in more than 95% of the lung cancer samples tested, with a “false positive” rate of less than 5% of the control samples tested. This result was validated by randomly splitting cancer and control samples in “training” sets and “validation” sets using the training sets for defining the antigen composition and applying these to the validation sets. This method demonstrated an average sensitivity above 90% with less than 10% false positives for the validation sets. However, larger samples sizes are expected to produce even better results.

Confirmation Study

BARD1 has commenced Analytical Validation to further develop, optimise and validate the BARD1 Lung Cancer Test for early detection of lung cancer across multiple cohorts comprising lung cancers of different types and stages, patients’ age, gender and ethnicity on a proven ELISA platform. A Confirmation Study is underway in 450 lung cancer samples and healthy controls with results expected in 1Q17.