A research team led by scientists at Provista Diagnostics has released data from a new study showing that a multiprotein biomarker blood test to detect breast cancer, Videssa® Breast, can help inform better decision-making after abnormal mammogram or other breast imaging results and potentially reduce the use of traditional biopsy by up to 67%.
Findings from the new study were published recently in Clinical Breast Cancer, in an article entitled “A Non-Invasive Blood-Based Combinatorial Proteomic Biomarker Assay to Detect Breast Cancer in Women Under the Age of 50 Years.”
“With about 1.6 million breast biopsies performed each year, the implications of a blood test that can help clinicians confidently rule out breast cancer and avoid a potentially unnecessary biopsy are tremendous,” explained CMO of Provista Diagnostics Judith Wolf, M.D., who was not directly involved in the study. “We know imaging has limitations, especially among women under age 50, who, because of confounding factors, are more difficult to image. This research shows that Videssa Breast can be a powerful new tool in the diagnostic toolbox for clinicians.”
The new study evaluated the performance of the multiprotein biomarker liquid biopsy test among women under age 50. Participants were enrolled into two prospective trials that recruited 545 women, ages 25 to 50, with abnormal or difficult-to-interpret imaging (BI-RADS 3 and 4). The overall performance of the liquid biopsy 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 study authors noted 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 the technique over imaging—25.2% vs. 8.8%—can increase the percentage of biopsies that yield a breast cancer diagnosis from 1 in 11 to 1 in 4.
“When a mammogram yields an abnormal result, the challenge for every clinician is to decide which patients need follow-up, further imaging, or biopsy,” noted study co-author Josie Alpers, M.D., a radiologist specializing in mammography and diagnostic radiology at Avera McKennan Hospital & University Health Center. “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 Videssa Breast assay has been employed in two prospective, randomized, multicenter, and blinded clinical trials, in more than 1350 patients ages 25 to 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.
The researchers have expressed optimism about future studies using the liquid biopsy technique.
“The test exhibited consistently high specificity and negative predictive value in all test sets in a prospective manner, further supporting its clinical use in this intended-use population,” the study concluded. “Additional model development is currently being conducted to maximize sensitivity, thereby increasing clinical utility as a biopsy rule-out test.”