BARD1 Life Sciences (ASX: BD1) has validated the commercial potential of its ovarian cancer screening test after new research revealed the test’s accuracy in detecting the disease in high-risk women.
The new study shows the BARD1-Ovarian screening test has a high accuracy in determining ovarian cancer in women who or are carrying the BRCA1/2 mutations, which predisposes them to these cancers. The test is also accurate in women who have a family history of ovarian and breast cancer.
“As people have become aware of their genetic make-up and predisposition to disease, they want to take action to protect their health,” BARD1 executive director Dr Irmgard Irminger-Finger said.
“For some, like Angelina Jolie, this means electing to undergo radical, preventative surgery.”
“The great hope of medical science is that accurate testing can detect early stage cancer and deliver health choices and outcomes to patients.”
Dr Irminger-Finger added most current ovarian cancer tests are only accurate during the disease’s later stages.
“BARD1-Ovarian has demonstrated high accuracy to detect ovarian cancer at early stages and these latest research findings underline how significant the test can be in routine screening of high-risk woman to improve survival and avoid unnecessary surgery,” Dr Irminger-Finger noted.
During the study, 261 plasma samples were screened with BARD1-Ovarian possessing a 89% sensitivity and 97% specificity in the test sets.
BARD1-Ovarian works by measuring BARD1 autoantibodies and CA125 in blood. A proprietary diagnostic algorithm combines these levels into a cancer score that estimates the presence or absence of ovarian cancer.
The test’s accuracy was highest in women with the BRCA1/BARD1 mutations with a 100% sensitivity and 90% specificity. The detection was independent of cancer stage.
Commercial potential of BARD1-Ovarian
According to BARD1, these latest results enhance the BARD1-Ovarian screening test’s commercial potential to tap into the growing global market for early cancer detection, which has been underpinned by advances in genetic science.
The company claims current screening procedures for breast cancer in high-risk individuals include mammography, with no reliable ovarian cancer screening test available apart from the CA125 blood test which has a less than 50% sensitivity in detecting the disease during early stages.
BARD1 anticipates it will take about two years to advance the product further if future clinical studies continue delivering the expected positive results.
The company is targeting launching BARD1-Ovarian as a laboratory developed test in Australia and the US by 2021, where it can be widely used to detect the disease in high-risk asymptomatic women and symptomatic women.
Shares in BARD1 were up almost 8% to $0.014 by early afternoon trade.