Blood Test Offers Improved Breast Cancer Detection

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.

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