Provista Diagnostics is 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 cancers. Our first commercial product, Videssa® Breast, is focused on early breast cancer detection, while additional products in development will focus on gynecologic cancers such as ovarian, endometrial and HPV-associated. Provista’s state-of-the-art, high-complexity clinical laboratory is accredited by the College of American Pathologists (CAP) and the Clinical Laboratory Improvement Amendments (CLIA).
In the US market, approximately 50 percent of women (15.5 million) undergoing mammography have a dense breast classification. Breast density impacts a physician's ability to identify cancers at an early stage. Over half of the country has enacted legislation requiring healthcare providers to inform patients of breast density at the time of screening. In addition, 5.2 million women annually have breast imaging results where the presence of malignancy is difficult to determine. In these situations additional imaging and biopsies are typically required. Of the 1.7 million biopsies performed annually, 70 to 90 percent result in a benign diagnosis. For these healthcare providers, an additional diagnostic test, such as Videssa® Breast can provide clarity. Provista's clinical trials observed that 98 to 99 percent of women with a negative Videssa Breast test result will not have cancer and therefore can forego additional imaging and biopsies. By providing additional information, Videssa Breast can help minimize patient anxiety and reduce overall health costs.
Provista's proprietary ProteoMark® Technology detects and analyzes multiple tumor protein biomarkers for improved cancer detection. Unlike other blood-based technologies (such as circulating tumor cells and cell-free DNA), breast cancer tumor proteins are well understood in the scientific literature and easily identified in blood, which offers a more effective approach for cancer detection.
Videssa Breast is the first protein-based blood test of its kind to provide early and accurate detection of breast cancer. Videssa Breast may provide clarity to women who receive ambiguous mammography results and/or have dense breasts. With a simple blood draw, Videssa Breast can help healthcare providers determine with greater confidence, whether further diagnostic procedures are warranted or provide assurance that a patient likely does not have breast cancer.
Videssa Breast is a Laboratory Developed Test (LDT), developed by Provista Diagnostics, Inc. Provista is accredited by the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP), which govern the approval of LDTs. Videssa Breast is used for clinical purposes and should not be regarded as investigational or for research only purposes.
Provista’s intellectual property portfolio includes 17 issued and pending patents. Our ProteoMark Technology utilizes in-licensed autoantibody technologies which were discovered and developed at Dana-Farber Cancer Institute, Harvard University and the Biodesign Institute of Arizona State University. Provista is in the process of pursuing high-quality IP from universities and research institutes around the globe.
Provista is currently developing several diagnostics tests to address unmet needs in women’s cancers, including breast, ovarian, endometrial and HPV-associated cancers. Provista’s diagnostic tests are designed to complement the current standard-of-care and provide an additional tool for early detection. Videssa Breast is Provista’s lead diagnostic, which is the first protein-based blood test of its kind to provide early and accurate detection of breast cancer. Provista’s proprietary ProteoMark Technology allows for continued development in Provista’s robust pipeline of breast and gynecological cancers.