Provista Diagnostics Announces Key Data Presented at the American Society of Clinical Oncologist Breast 2014 Annual Meeting 

Data Demonstrates the Ability of Serum Protein Biomarkers in Conjunction with Autoantibodies to Distinguish Between Invasive Breast Cancer and Benign Breast Conditions

New York, NY – September 8, 2014 – Provista Diagnostics, Inc., a privately-held molecular diagnostics company focused on developing and commercializing proprietary blood-based diagnostic, prognostic and monitoring tests for cancers affecting women, today announced data highlighting Provista’s proteomic diagnostic

that measures multiple breast cancer-specific biomarker proteins in blood samples. The company presented this data in a poster at The American Society of Clinical Oncology’s 2014 Breast Cancer Symposium (ASCO-Breast 2014) that took place from September 4-6, 2014 in San Francisco. 

The poster titled, “Combining serum autoantibody measurements with serum protein biomarkers for the detection of invasive breast cancer,” was presented on September 5^th during two Risk Assessment, Prevention, Early Detection, Screening, and Systemic Therapy Sessions

The poster highlighted data from a study that measured serum protein biomarkers (SPBs) known to be associated with breast cancer in over 163 serum samples from women with either breast cancer or benign breast conditions.  In addition, 28 autoantibodies (AAbs) associated with cancer were analyzed in 31 of these patients.  The research demonstrated that the addition of AAbs to a panel of SPBs greatly increases accuracy and using SPBs to distinguish benign from invasive breast cancer yields reasonable but non-clinically meaningful results in menopausal women.

Provista Diagnostics currently has multiple randomized prospective trials underway to establish the combined role SPBs and AAbs to differentiate benign from invasive breast cancers.  Data from these studies is expected to be available by year end. 

“The presentation of this proof-of-concept data is a major milestone for Provista as we continue to advance the development of our robust pipeline to detect breast and gynecologic cancers in women,” said David Reese, PhD, President and CEO of Provista.  “Accurate clinical diagnosis of breast cancer depends on the effective use of complementary technologies in conjunction with standard of care, such as imaging. We believe our proteomics approach, which combines the sensitivity of autoantibodies with the specificity of known serum protein biomarkers along with standard-of-care imaging, may reduce the number of missed actionable breast cancers while avoiding the stress and added diagnostic costs of false negative reports.” 

According to the American Cancer Society, nearly 233,000 women will be diagnosed with breast cancer in the U.S. in 2014. Approximately 40,000 deaths occur from breast cancer each year. While biomarkers are often used to augment detection of various cancers, definitive biomarkers for breast cancer have remained elusive.

About ASCO Breast 2014

The 2014 Breast Cancer Symposium is a 2½ -day multidisciplinary symposium that features presentations on the latest multidisciplinary research from selected theme-based translational and

clinical abstracts, as well as related educational sessions. This Symposium offers an opportunity for clinically relevant, in-depth discussions of how and when to translate new findings into patient care and how to be more selective about breast cancer therapy. The American Society of Breast Disease (ASBD), American Society of Breast Surgeons, American Society of Clinical Oncology (ASCO), American Society for Radiation Oncology (ASTRO), National Consortium of Breast Centers, Inc. (NCBC, Inc.), and Society of Surgical Oncology (SSO) are cosponsoring this event.

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.

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