A protein-based blood test can detect the presence of breast cancer, and may help lower the number of benign breast biopsies performed, according to data presented at the 101st Scientific Assembly & Annual Meeting of the Radiological Society of North America.1,2
In this prospective multi-center study, researchers sought to develop a blood-based diagnostic test, using multiple serum protein biomarkers (SPBs) and tumor-associated autoantibodies (TAAbs), to aid in cancer detection.1
A total of 508 patients aged 25 to 75 with BI-RADS 3 or 4 imaging were included: 300 in the training set and 208 in the validation set. Patients had no history of cancer, and no breast biopsy within 6 months.
Those not undergoing biopsy had imaging follow-up at 6 months. Investigators created multiple algorithms for breast cancer detection using the training set, then the data were validated in order to perform a retrospective analysis to refine sensitivity and specificity.
One model used 5 SPBs and 13 TAAbs and had an initial sensitivity of 82.2% , specificity of 82.5%, positive predictive value of 28.4%, and a negative predictive value of 97.5%.
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Of the 508 BI-RADS 3 or 4 patients, 344 were biopsied and 51 malignancies were found (14.8%), compared with the protein-based blood assay, which identified 148 patients for biopsy and 42 (28.4%) malignancies were found.
Using these data, Provista Diagnostics Inc. developed Videssa Breast, a protein-based blood test that is approved in 49 states and is scheduled to launch in 2016.2
“Provista’s technology is not only groundbreaking as a complimentary [sic] diagnostic, but is also backed by strong, prospective clinical trial data,” said Ana Lourenco, MD, of Rhode Island Medical Imaging who presented the data at the meeting. “I chose to present their findings because I wanted to ensure my fellow radiologists learned of it.”
- Lourenco AP, Reese DE, Corn C, et al. Proteomics at work: can a protein-based blood assay help detect breast cancer in women aged 25-75 with BI-RADS®3 or 4 imaging findings? Abstract presented at: 101st Scientific Assembly & Annual Meeting of the Radiological Society of North America; December 2, 2015; Chicago, IL.
- Provista diagnostics announces pivotal clinical results for Videssa® breast – a simple blood test for early and accurate breast cancer detection [press release]. New York, NY: PRNewswire; December 1, 2015.