BARD1 Biomarker Technology

INOVIQ’s proprietary BARD1 technology is a biomarker platform covering various BARD1 tumour markers, diagnostic, and therapeutic methods and uses in multiple cancers. BARD1 tumour markers have potential utility as diagnostic biomarkers for the detection and monitoring of cancer, and therapeutic targets for immunotherapies used in the treatment of cancer, including breast, ovarian, colorectal and other cancers.

How does BARD1 technology work?

INOVIQ has three autoantibody tests in development for early detection of ovarian, breast and lung cancers. BARD1 autoantibody tests measure autoantibodies to variant BARD1 proteins in the blood and use a proprietary cancer-specific algorithm to combine these levels into a cancer score that identifies the presence or absence of a specific cancer.

BARD1 autoantibodies reflect the body’s early immune response to tumour formation and are present in the early stages of cancer, enabling the BARD1 tests to detect cancer earlier across all cancer stages before symptoms appear.

BARD1 autoantibody tests

INOVIQ’s lead pipeline product is the BARD1-Ovarian test and it is in development for early detection of ovarian cancer. BARD1-Ovarian has shown excellent results in early studies, with diagnostic accuracy of 0.95 AUC, 88% sensitivity and 93% specificity for detection of ovarian cancer in average-risk women (OC-125 Study) and even higher diagnostic accuracy of 0.97 AUC, 89% sensitivity and 97% specificity in high-risk women with a family history of breast/ovarian cancer or carrying BRCA1/2 mutations (OC-R001 Study). BARD1-Ovarian has the potential to become an alternative ovarian cancer screening test in high-risk asymptomatic women with Hereditary Breast and Ovarian Cancer (HBOC) syndrome. It could also have utility as a follow up test when medical imaging results are unclear in symptomatic women or as an elective screening test in average-risk asymptomatic women.

INOVIQ’s second and highly complementary product is the BARD1-Breast test for early detection of breast cancer. BARD1-Breast has shown diagnostic accuracy of 0.86 AUC, 70% sensitivity and 88% specificity for detection of breast cancer in average-risk women (BC-001a Study) and could accurately distinguish malignant breast cancer from benign lesions with accuracy of 0.84 AUC, 85% sensitivity and 76% specificity (BC-001b Study). BARD1-Breast has the potential to be an alternative breast cancer screening test in average-risk asymptomatic women of all ages, including women with dense breast tissue.

INOVIQ is currently undertaking further assay design, development and technical validation before advancing to clinical development.