BARD1 Life Sciences expands success in non-invasive ovarian cancer test, moves to commercialisation

BARD1 Life Sciences (ASX: BD1) has pronounced additional success for its BARD1-Ovarian test after an independent test confirmed the non-invasive diagnostic tool’s “high accuracy” in detecting ovarian cancer.

The follow-on independent OC-400V study evaluated the strength of the BARD1-Ovarian algorithm on 82 ovarian cancers and 27 healthy controls.

In this latest study, “high accuracy” in detecting ovarian cancer was displayed with 89% sensitivity and 82% specificity – more precise than the previously announced results.

“This study provides further evidence of the robustness of the BARD1-Ovarian test,” BARD1 Life Sciences executive director Dr Irmgard Irminger-Finger said.

“Upon transfer to a commercial platform, our ongoing product development efforts will focus on testing BARD1-Ovarian in larger sample sets and the addition of other immunogenic markers to our biomarker panel to further train the algorithm and increase its accuracy for early detection of ovarian cancer,” Dr Irminger-Finger added.

These latest results are higher than the earlier OC-400 study that was reported in early January which returned 82% sensitivity and 79% specificity.

BARD1-Ovarian is a ELISA-based blood test which can identify ovarian cancer in its early stages. To do this, the diagnostic tool measures autoantibodies in the blood in conjunction with Bard1 Life Sciences’ proprietary algorithm to generate a score that can determine the presence of ovarian cancer.

In the original study, 400 ovarian cancer samples were used and matched with healthy controls.

BARD1-Ovarian commercial platform

Following these promising results, BARD1 Life Sciences is in discussions with several laboratory companies to transition the BARD1 research assay to a commercial platform.

Using the speciality and expertise in assay development and validation that the laboratory organisations possess, Bard1 Life Sciences aims to have its BARD1 tests eventually performed in hospital and independent clinical laboratories world-wide.

“BARD1 Life Sciences anticipates the transfer of our research assay to a commercial platform that will enable more efficient development and commercialisation of our diagnostic pipeline for detection of lung, ovarian and other cancers,” BARD1 Life Sciences chief executive officer Dr Leearne Hinch stated.

As one of the world’s leading causes of cancer deaths in women, ovarian cancer causes 152,000 fatalities globally, with 239,000 new cases identified in 2012.

Because the cancer isn’t usually detected to later stages due to its lack of symptoms, the diseases has often spread with the overall survival rate in the United States estimated at 46%.

The cancer also has a 70% chance of recurrence within 18 months. However, if ovarian cancer is caught early, survival rates are substantially increased to 92%.

BARD1 Life Sciences estimates the global ovarian cancer diagnostic market was valued at US$7.2 billion in 2013 and this number is forecast to rise to US$11.8 billion by 2020.

The market reacted positively to the news with company’s stock price rocketing 140% to A$0.024 by mid-morning trade.