NEW YORK, August 14, 2018 – Provista Diagnostics today reported the successful completion of the 28 state Videssa Breast assay pilot commercialization program involving 147 clinicians. The company is now preparing for a wider launch that will include strategic partners with strong commercial channels, after receiving feedback from the first women to use Videssa Breast for cancer detection.
“We are committed to addressing the unmet needs in early breast cancer detection with noninvasive diagnostics supplementing medical imaging. Completing this pilot rollout was critical in achieving that goal,” said Gary Altman, CEO of ProvistaDX.com. “With a negative predictive value greater than 98 percent, Videssa Breast is poised to transform how women are screened for cancers. The goal is not to miss a cancer. To that end we are currently engaged in discussions with potential commercial partners.”
The company’s plans include a prospective clinical study to build upon the recently completed clinical trials of Videssa Breast. The randomized, multi-center and blinded clinical trials completed last year demonstrated that using Videssa Breast has the potential to significantly reduce unnecessary biopsies by adding a simple blood test following suspicious mammograms where there is no clearly identified lesion to biopsy, irrespective of breast density.
“Videssa Breast truly is changing the way we approach diagnosis, especially with a population of high risk patients who may have challenging mammograms or images,” said Josie Alpers, MD, radiologist and Director of Mammography at Avera Breast Center. “As doctors, we have only so many cards to play in diagnosing breast cancer. This test adds another important tool that will, over time, prove to be invaluable.”
About Videssa® Breast
Videssa Breast is the only simple blood test to provide early and accurate detection of active breast cancer. In those women who present with suspicious 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. When used in combination with imaging, Videssa Breast offers the healthcare provider additional data leading to increased confidence and clarity when clinical assessment is challenging. In addition, for those women with genomic risk factors, Videssa can be a useful annual follow-on test.
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 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.
Media:
David Schull
Russo Partners LLC
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(212) 845-4271
Ned Berkowitz
Russo Partners LLC
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(646) 942-5629
