Image: The Videssa Breast protein biomarker blood test for breast cancer evaluates 11 serum protein biomarkers and 33 tumor-associated autoantibodies (Photo courtesy of Provista Diagnostics).
Breast cancer is predicted to be the second leading cause of cancer deaths in the USA women. Approximately 232,000 cases of invasive breast cancer and 60,000 cases of ductal carcinoma in situ (DCIS) are diagnosed and 40,000 deaths occur annually.
A multi-protein biomarker blood test that is able to detect breast cancer can help inform better decision-making after abnormal mammogram or other breast imaging results and potentially reduce use of biopsy by up to 67%. If diagnosed early in a localized state, five-year survival rates are greater than 98%.
Medical scientists working with a privately held molecular diagnostics company carried out two prospective, randomized, multi-center and blinded clinical trials, in more than 1,350 patients, ages 25-75. It is the first prospective study of a proteomic assay composed of serum protein biomarkers and tumor-associated autoantibodies being used to detect breast cancer in women with abnormal imaging results. Serum was evaluated for 11 serum protein biomarkers and 33 tumor-associated autoantibodies.
The team used the Videssa Breast (Provista Diagnostics, Inc, New York, NY, USA), which is the first blood-based proteomic test of its kind to provide early and accurate detection of breast cancer. The overall performance of Videssa Breast in women with a breast cancer prevalence of 5.87% resulted in a sensitivity of 87.5%, specificity of 83.8%, positive predictive value (PPV) of 25.2% and a negative predictive value (NPV) of 99.1%.
The authors noted that that the high NPV helps clinicians identify patients who are highly unlikely to have breast cancer. Depending on age, approximately 70% to 90% of breast biopsies are benign. The improved PPV of Videssa Breast over imaging of 25.2% versus 8.8% can increase the percentage of biopsies that yield a breast cancer diagnosis from one in 11 to one in four.
Josie R. Alpers, MD, a radiologist specializing in mammography and diagnostic radiology, and co-author, said, “When a mammogram yields an abnormal result, the challenge for every clinician is to decide which patients need follow-up, further imaging or biopsy. A test that is well-validated in a prospective trial means clinicians have a new way to accurately identify which patients may or may not need additional follow-up.” The study was published on May 23, 2017, in the journal Clinical Breast Cancer.