title: An Antibody-based Blood Test Utilizing a Panel of Biomarkers as a New Method for Improved Breast Cancer Diagnosis.
abstract: In order to develop a new tool for diagnosis of breast cancer based on autoantibodies against a panel of biomarkers, a clinical trial including blood samples from 507 subjects was conducted. All subjects showed a breast abnormality on exam or breast imaging and final biopsy pathology of either breast cancer patients or healthy controls. Using an enzyme-linked immunosorbent assay, the samples were tested for autoantibodies against a predetermined number of biomarkers in various models that were used to determine a diagnosis, which was compared to the clinical status. Our new assay achieved a sensitivity of 95.2% [CI = 92.8-96.8%] at a fixed specificity of 49.5%. Receiver-operator characteristic curve analysis showed an area under the curve of 80.1% [CI = 72.6-87.6%]. These results suggest that a blood test which is based on models comprising several autoantibodies to specific biomarkers may be a new and novel tool for improving the diagnostic evaluation of breast cancer.
authors: Eventus Diagnostics (Israel) Ltd., Ora, Israel.
authors: Galit
authors: G
authors: Yahalom
authors: Daria
authors: D
authors: Weiss
authors: Ilya
authors: I
authors: Novikov
authors: Therese B
authors: TB
authors: Bevers
authors: Laszlo G
authors: LG
authors: Radvanyi
authors: Mei
authors: M
authors: Liu
authors: Benjamin
authors: B
authors: Piura
authors: Stefano
authors: S
authors: Iacobelli
authors: Maria T
authors: MT
authors: Sandri
authors: Enrico
authors: E
authors: Cassano
authors: Tanir M
authors: TM
authors: Allweis
authors: Arie
authors: A
authors: Bitterman
authors: Pnina
authors: P
authors: Engelman
authors: Luis M
authors: LM
authors: Vence
authors: Marvin M
authors: MM
authors: Rosenberg
keywords: autoantibodies; biomarkers; breast cancer; diagnostic testing