SCOTTSDALE, Ariz., /PRNewswire/ -- Provista Diagnostics today announced the results of its latest clinical study of its simple blood test to further validate its proteomic biomarker assay, Videssa®. The article titled "A Non-Invasive Blood-Based Combinatorial Proteomic Biomarker Assay to Detect Breast Cancer in Women over age 50 with BI-RADS 3, 4, or 5 Assessment," was published in Clinical Cancer Research and is available at http://clincancerres.aacrjournals.org/content/early/2018/09/05/1078-0432.CCR-18-0843.
The study concluded that Videssa when used in conjunction with breast imaging improved breast cancer detection compared to mammography alone in women with moderate risk of malignancy. When combined with ProvistaDX's previously published data for women under age 50, Videssa achieves a comprehensive 93% sensitivity and 98% NPV in a population of women ages 25 - 75. Had Videssa results been incorporated into the clinical workflow, approximately 45% of biopsies might have been avoided.
This simple blood test is for the early detection of active breast cancer irrespective of breast density. "Videssa has again demonstrated it's a reliable and accurate method of detecting breast cancer when used in combination with mammography", said Gary Altman, CEO.
Performance of Videssa® from two prospective trials that enrolled 1,350 women, ages 25-75, with abnormal or difficult-to-interpret imaging (BI-RADS 3, 4 and 5) was evaluated. The study combined biomarker data with patient clinical data to develop a training cohort (469 women, cancer incidence: 18.5%), resulting in 94% sensitivity and 97% negative predictive value (NPV). Independent validation of the final algorithm in 194 subjects (BC incidence: 19.6%) demonstrated a sensitivity of 95% and a NPV of 97%.
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 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.
For additional information, please contact Gary Altman, CEO (AltmanG@ProvistaDX.com).
Provista Diagnostics, Inc. is a privately-held company located in Scottsdale, AZ.
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