Provista Diagnostics Presents Key Clinical Studies at The 2015 Miami Breast Cancer Conference®
New York, NY – March 9, 2015 – Provista Diagnostics, Inc., a privately-held molecular diagnostics company focused on
developing and commercializing a new generation of proprietary blood-based diagnostic, prognostic and monitoring tests designed to address the unmet needs in women’s cancer, such as breast and gynecologic cancers, today announced that they presented data from key clinical studies utilizing a proprietary novel blood-based combinatorial biomarker assay at The 2015 Miami Breast Cancer Conference®, held February 26 – March 1, 2015 in Miami, Florida.
In the presentation titled: Provista 002 – Interim Analysis of A Prospective, Multi-Center, Randomized Trial Utilizing the Provista Biomarker Assay in Conjunction with Imaging to Detect Breast Cancer from BI-RADS® 3 and 4 Patients Ages 25-75. In this initial cohort of 508 patients, Provista Diagnostics presented data that tested the ability of the breast biomarker assay to distinguish benign breast disease from invasive breast cancers to a broader patient population.
Provista 001- Human Breast Cancer Combinatorial Biomarker Serum Biopsy: The Final Study Report on the Multi-Center Prospective Study of Protein Signatures Used in the Detection of Invasive Breast Cancer/DCIS in Women Under the Age of 50 with a BI-RADS® 3 or 4 Assessment; Provista Diagnostics presented supporting data showing combinatorial protein signatures increased the precision of the diagnosis of breast cancer in women under 50 years when combined with standard of care.
“The data suggests our combinatorial biomarker panel is useful in informing the decision to biopsy or continue with 6-month follow-up,” said David Reese, PhD, Chief Executive Officer, Provista Diagnostics. “Furthermore and worthy of note, the detection of DCIS or breast cancer detection was irrespective of breast density.”
“The response was tremendous to these data at the Miami Breast Cancer Conference® and these findings provide further indication for the clinical utility of our flagship test to distinguish benign from malignant lesions in BI-RADS® 3 and 4 patients," Dr. Reese, continued. "The precise diagnosis of breast cancer is often confounded by the presence of benign breast tissue and high breast density in women. Thus, developing new technologies to detect biomarkers associated with breast cancer may assist in the precise detection of cancer in a broader population of women, suggesting utility in both pre- and post-menopausal patients."
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.
###
