BARD1-Ovarian is an ELISA-based blood test in development for early detection of ovarian cancer. The test measures multiple BARD1 autoantibodies in the blood and uses a proprietary diagnostic algorithm to combine these levels into a cancer score that identifies the presence or absence of ovarian cancer. BARD1-Ovarian could potentially be used as a screening test for early detection of ovarian cancer in high-risk asymptomatic individuals, for risk assessment of malignancy in women with pelvic masses, or to monitor ovarian cancer recurrence.
Ovarian cancer is the leading cause of gynaecological cancer deaths and seventh most common cancer in women worldwide, with around 239,000 new cases diagnosed and 152,000 deaths in 2012. Ovarian cancer is often diagnosed at a late stage after symptoms have appeared, resulting in a poor prognosis with an overall 5-year survival rate of 46% in the US, and recurrence of around 70% after 12-18 months. Earlier detection by finding ovarian cancer when local rather than distant may increase 5-year survival from 29% to 92%, a potential survival improvement of 3 times. There is a clear unmet clinical need for non-invasive, accurate and affordable diagnostic tests for the early detection and monitoring of ovarian cancer. The global ovarian cancer diagnostics market was valued at US$7.2B in 2013 and is expected to grow at 7.2% annually to reach US $11.8B by 2020.
BARD1 has completed multiple pilot studies to evaluate and optimise the BARD1-Ovarian biomarker panel and algorithm for detection of ovarian cancer.
These retrospective, case-control studies in ovarian cancer samples and healthy controls showed the accuracy of research BARD1-Ovarian panels at discriminating people with and without ovarian cancer, and the potential of developing a commercial BARD1-Ovarian test with high sensitivity and specificity for early detection of ovarian cancer.
Study results have demonstrated that BARD1-Ovarian has diagnostic accuracy of up to 0.88, 89% sensitivity and 82% specificity for detection of ovarian cancer.
Additional analytical and clinical validation studies are planned to further develop, optimise and validate BARD1-Ovarian for early detection of ovarian cancer.
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