BARD1 Life Sciences (ASX: BD1), a biotechnology company developing a non-invasive cancer diagnostics test for ovarian cancer, announced encouraging results today from an improved BARD1-Ovarian test that demonstrated “excellent diagnostic accuracy” of AUC 0.95, 88% sensitivity and 93% specificity for detection of ovarian cancer in test sets.
The company has previously established high accuracy rates in detecting ovarian cancer through an independent study published earlier this year.
In its most recent study, BARD1 evaluated and gauged the accuracy of its diagnostic “algorithm” by conducting comparative tests to detect ovarian cancer in 200 ovarian samples and 200 healthy controls.
The results demonstrated that BARD1’s combined “BARD1-CA125 algorithm” outperformed the BARD1 algorithm alone and CA125 alone for detection of ovarian cancer.
The combined BARD1-CA125 algorithm had excellent diagnostic accuracy with an average AUC 0.98 in training sets, and an average AUC 0.95, 88% sensitivity and 93% specificity in test sets.
The company said that addition of the CA125 to the BARD1-Ovarian test “increased sensitivity for detection of ovarian cancer by 6% and specificity by 14% over the previously reported OC-400 study results for the BARD1 algorithm alone.”
The high sensitivity and low false positive rate of the improved BARD1-Ovarian test demonstrated its potential to be further developed as a screening test for ovarian cancer in asymptomatic women and as an aid in the diagnosis of ovarian cancer in symptomatic women.
“CA125 values correlate with tumour burden and more accurately detect late-stage cancer, whereas BARD1 autoantibodies reflect the early immune response to tumour formation and are present from early to late-stage cancer, hence the BARD1-CA125 combination is presumed to more accurately detect early and late stages,” said Dr Irmgard Irminger-Finger, executive director and chief scientific officer of BARD1 Life Sciences.
Dr Irminger-Finger added that “this study confirmed that addition of CA125 to the BARD1-Ovarian test, improved its sensitivity across all stages and reduced false positives. Our goal is to develop BARD1-Ovarian as an accurate and reliable screening test for early detection of ovarian cancer when it can be potentially cured and help save women’s lives.”
The test results raise hopes that BARD1 can now displace other less-effective ovarian cancer screening methods currently being used by medical professionals.
“The results of the study presented by BARD1 Life Sciences, with a AUC=0.95 in test sets, surpass those for previously reported biomarkers. Therefore, the combined BARD1 OC-CA125 algorithm has the potential to replace other tests that are currently available and become the state of the art test especially for early-stage ovarian cancers,” said Professor Robert Zeillinger from the Medical University of Vienna in Austria.
In a statement to the market, BARD1 said that it intends to conduct clinical studies to evaluate the clinical performance of BARD1-Ovarian for screening and diagnosis of ovarian cancer.
Today’s news helped BARD1 shares to rise by 20% up to $0.018 per share in morning trade.