A new study has demonstrated that Videssa Breast, a multiprotein biomarker blood test for breast cancer by Provista Diagnostics, Scottsdale, Ariz, is unaffected by breast density and can reliably rule out breast cancer among women with both dense and non-dense breast tissue. Nearly half of all women in the United States have dense breast tissue.
“Women who have dense breasts are at a double disadvantage,” says Judith K. Wolf, MD, chief medical officer at Provista Diagnostics. “Not only are they at higher risk of developing breast cancer, but dense breast tissue can decrease the reliability of imaging and increase the chances of a false finding. This study shows that, with an over 99% negative predictive value (NPV), clinicians can confidently use Videssa Breast to detect cancer in women with dense breasts and better determine when biopsy is truly warranted to assess suspicious findings.”
The study evaluated the performance of Videssa Breast among 545 women, aged 25 to 50, with abnormal or difficult-to-interpret imaging (category 3 or 4 according to the Breast Imaging Reporting and Data System). In the dense breast group, sensitivity and specificity were 88.9% and 81.2%, respectively. In the non-dense breast group, sensitivity and specificity were 92.3% and 86.6% , respectively. The differences were not statistically significant. The NPV was 99.1% among women who had dense breasts, and 99.3% among women with non-dense tissue, providing confirmation that when a woman receives a negative test result, she does not have breast cancer.
In recent years, the challenges of diagnosing breast cancer in women with dense breasts has drawn national attention. Driven by patient advocacy groups such as Are You Dense Inc and Are You Dense Advocacy Inc, 32 states have enacted legislation to ensure that women are informed of their breast density status and the associated diagnostic challenges.
“Using biomarkers for cancer detection is an important advance in managing women with dense breasts and navigating many diagnostic challenges,” says Elayne Arterbery, MD, radiation oncologist at St. Mary’s of Saginaw, and a principal investigator on the Provista study. “As a clinician, the ability to identify who will benefit most from further imaging and follow-up, and to rule out breast cancer in women, when they receive suspicious findings, is tremendous. This study also validates the scientific promise and growing role biomarkers have in addressing diagnostic challenges for women with dense breasts, and the merits of further research to help expand how we put that science to work to benefit women.”
Videssa Breast has been studied in two prospective, randomized, multicenter, and blinded clinical trials, in more than 1,350 patients aged 25 to 75. Data featured in the new publication were taken from the first study and cohort one of the second study. Videssa Breast is currently available for use by ordering healthcare providers for patients with abnormal imaging findings.
With a simple blood draw, Videssa Breast can help guide further diagnostic procedures or provide assurance that the patient does not have breast cancer. Videssa Breast transforms the breast cancer detection paradigm and applies proteomic testing to bring clarity to imaging results.
For more information, visit Provista Diagnostics.
- Reese DE, Henderson MC, Silver M. Breast density does not impact the ability of Videssa Breast to detect breast cancer in women under age 50. PLoS One. 2017;12(10):e0186198; doi: 10.1371/journal.pone.0186198.