Perth-based biotech company BARD1 Life Sciences (ASX: BD1) has developed a world-first blood test for the early detection of breast cancer, claiming high diagnostic accuracy and the ability to distinguish between malignant and benign lesions.
The breakthrough BARD1 BC test – which uses the same diagnostic platform as the company’s ovarian cancer screening test – provides for the monitoring and early detection of cancer in high-risk women with familial accumulation of breast cancers or identified mutations in the BRCA 1 and 2 breast cancer genes.
It has been designed to measure BARD1 auto-antibodies in a patient’s blood and uses a proprietary breast cancer-specific algorithm to combine these levels into a “cancer score” which identifies the presence or absence of breast cancer.
Results from BARD1’s research studies have shown the test has a high diagnostic accuracy rate for detection across all sub-types and stages with AUC (area under the curve) of 0.86, 70% sensitivity and 88% specificity.
Importantly, the test has been proven as an aid in confirming the classification of suspicious lesions detected by mammography.
Such lesions can currently only be confirmed via excisional, incisional or needle aspiration biopsies followed by histopathology-based diagnosis.
Filling a market gap
Chief executive officer Dr Leearne Hinch said the BARD1 BC test fills a gap in a market which currently does not provide a blood test for early detection.
“This development addresses an unmet need for an accurate, reliable and affordable blood test to detect breast cancer early,” she said.
“It could also potentially screen average-risk asymptomatic women to detect breast cancer earlier, increase screening uptake, improve survival and reduce healthcare costs.”
According to industry research, the global breast cancer diagnostics market is expected to grow at 8.8% annually to reach $51.5 billion by 2020.
Dr Hinch said this growth represents a significant global market opportunity for an effective breast cancer screening test.
She said the company will conduct additional studies involving large cohorts in order to further develop, optimise and evaluate the effectiveness of the BARD1 BC test.
The studies will comprise different breast cancer types and stages, benign breast lesions, and healthy controls to improve the diagnostic accuracy for early detection.
Ovarian test results
The breast cancer test results follow positive developments last month from a study into the commercial validation of BARD1’s ovarian cancer screening test for pre-disposed women carrying the BRCA 1 and 2 mutations.
That study showed the test to have high diagnostic accuracy for early detection of ovarian cancer.
“Genetic testing for BRCA mutations is recommended for women with a family history of breast and ovarian cancers and can help determine if someone is a carrier of mutations or at a higher lifetime risk of developing [these] cancers,” Dr Hinch said.
“However, genetic tests do not detect if a woman has breast or ovarian cancer.”
She said the BARD1 BC and BARD1-Ovarian tests could potentially follow the genetic testing process and provide tools to regularly monitor high-risk women for early detection, thereby avoiding unnecessary surgery and potentially saving lives.
In the meantime, the company plans to focus its efforts on the parallel development and commercialisation of the ovarian and breast cancer tests over the next two years with market launch of both expected by early 2021.
It will engage with leading gynaecological and surgical oncologists, research clinicians and biostatisticians to prepare a clinical testing plan for early detection of breast and ovarian cancers and to initiate a prospective collection of biospecimens to enable rapid commencement of clinical studies in 2019.
Breast cancer facts
According to the World Health Organisation, breast cancer is the most common cancer in women worldwide and the second leading cause of cancer overall (after lung cancer), with around 2.1 million new cases diagnosed and 626,679 deaths in 2018 alone.
In Australia, the United States and Europe, breast cancer is currently detected using regular screening with mammography for average-risk, asymptomatic women, with the inclusion of MRI (magnetic resonance imaging) scans for those at high risk due to family history, genetic mutations or previous chest radiation therapy.
While mammograms have been considered the best screening test currently available, their limitations include acceptance and compliance; issues with false negatives and false positives (particularly in women with dense breast tissue) resulting in missed diagnosis, anxiety, over-diagnosis and over-treatment; and the fact that not all women are eligible or have access to tests due to costs, inconvenience or unavailability, particularly in developing countries.
At mid-afternoon trade, shares in BARD1 Life Sciences were up 114.29% to $0.030.