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Provista Diagnostics Announces Pivotal Clinical Results for Videssa Breast – A Simple Blood Test for Early and Accurate Breast Cancer Detection

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Provista Diagnostics, Inc. recently announced that Ana Lourenco, M.D. of Rhode Island Medical Imaging, will present data from their second prospective clinical study at the 101st Scientific Assembly & Annual Meeting of the Radiological Society of North America (RSNA) in Chicago, IL. Dr. Lourenco will be presenting “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?” as part of the Breast Imaging (Practice Issues) Education Session. The presentation will take place on Wednesday, December 2, 2015 at 3:20 PM in meeting room E451A at the McCormick Place Lakeside Center in Chicago, IL.

Provista’s prospective, blinded, randomized, study enrolled over 500 patients from 10 breast cancer centers across the United States and included women ages 25-75 who had a BI-RADS 3 (probably benign) or BI-RADS 4 (suspicious) finding on imaging. The goal of this study was to develop a blood based diagnostic test, consisting of multiple serum protein biomarkers and tumor associated autoantibodies, to aid in the detection of breast cancer. Data from this study demonstrated the ability of Provista’s biomarker assay to accurately detect the presence or absence of invasive breast cancer and/or DCIS with a high sensitivity, specificity, negative predicative value (NPV) and positive predictive value (PPV).

“Provista’s technology is not only groundbreaking as a complimentary diagnostic, but is also backed by strong, prospective clinical trial data,” said Dr. Lourenco. “I chose to present their findings because I wanted to ensure my fellow radiologists learned of it.”

With this data, Provista has developed Videssa® Breast, a protein-based blood test that can accurately detect the presence or absence of breast cancer. Videssa® Breast detects breast cancer, rather than assessing a patient’s risk for developing cancer in the future by identifying early warning signals of breast cancer, called biomarkers. The combination of this proteomic approach with traditional imaging provides concrete biochemical evidence allowing for improved diagnostic accuracy and greater confidence in clinical decision-making. Provista’s diagnostic test can help determine when further clinical evaluation is warranted, theoretically decreasing the rate of false positive and false negative results.

“Provista is honored to have Dr. Lourenco present our data at this year’s RSNA meeting,” said David Reese, Ph. D., President and Chief Executive Officer of Provista Diagnostics. “As a participant of our clinical trials and a well-respected radiologist, Dr. Lourenco provides valuable insight and validity to our data amongst a large group of peers.”

Videssa® Breast is a Laboratory Developed Test, currently approved for sale in 49 states with a projected commercial launch date in 2016.

Source: PR Newswire