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Provista Diagnostics Joins Cancer Moonshot-Inspired Collaborative to Advance Blood Tests for Cancer

Collaboration across biotech, government and academia will support Blood Profiling Atlas Pilot

NEW YORK, December 13, 2016 – Provista Diagnostics has joined a new collaborative announced in response to the White House Cancer Moonshot, the Blood Profiling Atlas. The Atlas is a collaborative effort among more than 20 organizations in biotech, government and academia, working to accelerate the development of blood-based cancer diagnostic technologies.

Provista’s commitment will center on sharing data generated during the development of Videssa® Breast, a protein-based breast cancer blood test and the company's first commercial product. Provista’s contribution will include data on both the pre-analytic variables including the accuracy, precision and stability of serum protein biomarkers (SPBs) and tumor-associated autoantibodies (TAAbs).

“For the cancer research community, the Blood Profiling Atlas is poised to foster important leaps forward in using blood tests to detect and identify cancers,” said David E. Reese, Ph.D., President and CEO of Provista Diagnostics. “Establishing rigorous standard methods for serum collection and handling and assessing biomarker significance will be critical to success. We know serum, and we’re pleased to contribute our expertise to help advance this collaboration.”

Provista’s contributed datasets will become part of the aggregated, freely available and harmonized Blood Profiling Atlas database, which will also include raw datasets from circulating tumor cells, circulating tumor DNA, and exosome assays as well as relevant clinical data (e.g. clinical diagnosis, treatment history and outcomes), and other sample preparation and handling protocols.

Provista is using proteomics to resolve diagnostic ambiguities via liquid biopsy in women's cancers. In breast cancer, Provista is using its ProteoMark® technology to enhance the diagnosis of breast cancer in women with inconclusive imaging.

“The Blood Profiling Atlas is a smart effort that zeroes in on one of our greatest scientific opportunities to make a difference in the lives of people. As the understanding of both genomic and proteomic approaches continues to grow, we look forward to working with partners to also assess the feasibility of proteomic and genomic approaches used concomitantly from the same sample,” said Reese.

Videssa Breast has been evaluated in large, prospectively collected, blinded, randomized, multi-center clinical trials. Current and upcoming publications will further elucidate the clinical utility of SPBs and TAAbs included in Videssa Breast to aid in the early detection of breast cancer. Videssa Breast is currently in limited clinical use through Provista’s early access program.

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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 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

About the Cancer Moonshot Blood Profiling Atlas

In response to the Vice President's call to action and in alignment with the goals of the Cancer Moonshot, representatives from government, academic, pharmaceutical and diagnostic companies are collaborating to create an open database for liquid biopsies to potentially accelerate the development of safe and effective blood profiling diagnostic technologies for patient benefit. Stakeholders will support the Blood Profiling Atlas pilot to aggregate, make freely available and harmonize for further analysis raw datasets, relevant clinical data and sample preparation and handling protocols. For more information visit https://www.whitehouse.gov/the-press-office/2016/10/17/fact-sheet-vice-president-biden-delivers-cancer-moonshot-report

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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