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

Data to be Presented at the 101st Scientific Assembly & Annual Meeting of the Radiological Society of North America

New York, NY – December 1, 2015 – Provista Diagnostics, Inc. today 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.

About RSNA

The Radiological Society of North America (RSNA®) is an international society of radiologists, medical physicists and other medical professionals with more than 54,000 members from 136 countries across the globe. RSNA hosts the world’s premier radiology forum, drawing approximately 55,000 attendees annually to McCormick Place in Chicago, and publishes two top peer-reviewed journals: Radiology, the highest-impact scientific journal in the field, and RadioGraphics, the only journal dedicated to continuing education in radiology. This years’ conference is being held from November 30 – December 3, 2015.

More information about RSNA can be found here RSNA.org

About Videssa® Breast

Videssa® Breast is the first blood-based proteomic test of its kind to provide early and accurate detection of breast cancer. In women who present with abnormal or difficult-to-interpret mammography results, the decision whether to order additional imaging or biopsy can be difficult. With a simple blood draw, Videssa® Breast can help guide further diagnostic procedures or provide assurance that the patient does not have breast cancer. Videssa® Breast transforms the breast cancer detection paradigm and applies proteomic testing to bring clarity to imaging results. When used in combination with imaging, Videssa® Breast improves diagnostic accuracy and provides greater confidence and clarity when clinical assessment is challenging. 

About Provista

Provista Diagnostics is a privately held molecular diagnostics company focused on developing and commercializing a new generation of proprietary blood-based proteomic diagnostic, prognostic and monitoring tests designed to address the unmet needs in women’s cancer, such as breast and gynecologic cancers. Provista Diagnostics’ state-of-the-art, high-complexity clinical laboratory is accredited by the College of American Pathologists (CAP) and with the Clinical Laboratory Improvement Amendments (CLIA).

Additional information about Provista Diagnostics is available at ProvistaDx.com

Information about Provista Diagnostics’ clinical trials is available at ClinicalTrials.gov

Safe Harbor Statement

Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Provista’s actual results may differ materially due to a number of factors, many of which are beyond Provista’s ability to predict or control, including among others, viability and effectiveness of our sales approach and overall marketing strategies, the outcome of development or regulatory review of our products, commercial success or acceptance by the medical community, competitive responses, our ability to raise additional capital, and the ability to successfully file a registration statement with the SEC. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. Provista operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Provista undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.

###