Ann: Results of BARD1 Ovarian Cancer Study, page-2

BARD1 ANNOUNCES POSITIVE RESULTS FROM OC-400 STUDY OF BARD1-OVARIAN TEST • Successful completion of OC-400 Study to evaluate the accuracy of BARD1-Ovarian for detection of ovarian cancer using the POC method • Results showed high accuracy of BARD1-Ovarian with an average AUC 0.92 in training sets, and an average AUC 0.88, 82% sensitivity and 79% specificity in test sets • Study concluded that BARD1-Ovarian accurately detected ovarian cancer, and confirmed its potential to be further developed into a commercial test for early detection of ovarian cancer Perth, Australia, 9 January 2018: BARD1 Life Sciences Limited (ASX:BD1), a biotechnology company developing non-invasive cancer diagnostics, today announced positive results from its OC-400 Study that showed BARD1-Ovarian achieved high accuracy for detection of ovarian cancer with an average AUC (area under the curve) of 0.92 in the training sets, and an average AUC of 0.88, 82% sensitivity and 79% specificity in the test sets. BARD1 has successfully completed the retrospective, case-control, OC-400 Study to evaluate the accuracy of the multi-analyte BARD1-Ovarian test to detect ovarian cancer in 400 female bio-banked samples of ovarian cancer and aged-matched healthy controls. The objectives of the study were to optimise the BARD1 panel and algorithm used in BARD1-Ovarian for early detection of ovarian cancer and to evaluate the accuracy of the test using the POC (proof-of-concept) method1 on a panel of 20 peptides (analytes). Data analysis generated a model with an average AUC of 0.92, 90% sensitivity and 85% specificity in the training sets, and an average AUC of 0.88, 82% sensitivity and 79% specificity in the cross-validation test sets. Table 1 summarises the results of BARD1-Ovarian in the OC-400 Study including AUC, sensitivity and specificity. Table 1: BARD1-Ovarian test results in OC-400 Study Study Samples Training Sets Test Sets n (cancer:normal) AUC Sensitivity Specificity AUC Sensitivity Specificity OC-400 Study2 400 (200:200) 0.92 90% 85% 0.88 82% 79% * Independent test set analysis The results of the OC-400 Study confirmed previous study findings that BARD1-Ovarian could accurately detect ovarian cancer with high sensitivity and specificity. Importantly, these results were achieved using less analytes reducing the complexity and cost of the BARD1-Ovarian test, which may offer improved performance over the CA125 blood test that is routinely used as a diagnostic aid for ovarian cancer. The study concluded that BARD1-Ovarian accurately discriminated ovarian cancer from healthy controls using the POC method and a 20-analyte panel, could detect all subtypes and stages of ovarian cancer, and confirmed the potential of the research-grade test to be further developed into a commercial test with expected high sensitivity and specificity for early detection of ovarian cancer. BARD1 Executive Director and CSO, Dr Irmgard Irminger-Finger, said “this study showed that using the POC method, BARD1-Ovarian achieved better sensitivity and specificity in a sample set from multiplesites with a reduced number of analytes than previously reported in the OC-300 Study.” 1 Pilyugin M, Descloux P, André P-A, Laszlo V, Dome B, Hegedus B, et al. (2017) BARD1 serum autoantibodies for early detection of lung cancer. PLoS ONE 12(8): e0182356. https://doi.org/10.1371/journal.pone.0182356 2 BARD1 LSL. OC-400 Study. Data on file. Jan 2018 BARD1 LSL | ASX Release BARD1 | ASX Release 2 “The positive results achieved in this OC-400 Study confirmed the potential of BARD1-Ovarian to accurately detect ovarian cancer with high sensitivity and specificity,” said Dr Leearne Hinch, BARD1 CEO. “The reduced analyte panel is an important step forward in the development of an accurate and affordable BARD1-Ovarian test for early detection of ovarian cancer.” BARD1 intends to advance the development of BARD1-Ovarian for early detection of ovarian cancer including outsourcing further assay development to a contract development organisation to build a commercial test, complete technical validation, and undertake clinical validation studies to demonstrate its clinical performance and support future marketing and/or licensing of the test. - ENDS -