Biomarker for breast cancer unaffected by breast density

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A study has demonstrated that Videssa Breast, a multi-protein biomarker blood test for breast cancer, is unaffected by breast density and can reliably rule out breast cancer in women with both dense and non-dense breast tissue. Nearly half of all women in the US have dense breast tissue.

“Women who have dense breasts are at a double disadvantage. 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.” said Dr Judith K Wolf, chief medical officer of Provista Diagnostics Inc. “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, ages 25 to 50, with abnormal or difficult-to-interpret imaging (BI-RADS 3 and 4). The sensitivity and specificity in the dense breast group was 88.9% and 81.2% respectively, and 92.3% and 86.6% in the non-dense group. The differences were not statistically significant. The NPV was 99.1% in women who had dense breasts and 99.3 in women with non-dense tissue, providing confirmation that when a woman receives a negative test result, she does not have breast cancer.

The challenges of diagnosing breast cancer in women with dense breasts has drawn national attention in recent years. Driven by patient advocacy groups such as Are You Dense Inc and Are You Dense Advocacy Inc, 32 states have enacted legislation to ensure women are informed of their breast density status and the associated diagnostic challenges.

An earlier study proved the utility of Videssa Breast as a diagnostic complement to imaging for women with abnormal findings and demonstrated it could potentially reduce use of biopsy by up to 67%. “Using biomarkers for cancer detection is an important advance in managing women with dense breasts and navigating many diagnostic challenges. As a clinician, the ability to identify who will benefit most from further imaging and follow-up, and rule out breast cancer in women, when they receive suspicious findings, is tremendous,” says Dr Elayne Arterbery, radiation oncologist at St Mary’s of Saginaw, who was a principal investigator on the Provista studies. “This study also validates the scientific promise and the 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, randomised, multi-centre and blinded clinical trials, in more than 1,350 patients ages 25 to 75.

Abstract
Breast density is associated with reduced imaging resolution in the detection of breast cancer. A biochemical approach that is not affected by density would provide an important tool to healthcare professionals who are managing women with dense breasts and suspicious imaging findings. Videssa® Breast is a combinatorial proteomic biomarker assay (CPBA), comprised of Serum Protein Biomarkers (SPB) and Tumor Associated Autoantibodies (TAAb) integrated with patient-specific clinical data to produce a diagnostic score that reliably detects breast cancer (BC) as an adjunctive tool to imaging. The performance of Videssa® Breast was evaluated in the dense (a and b) and non-dense (c and d) groups in a population of n = 545 women under age 50. The sensitivity and specificity in the dense breast group were calculated to be 88.9% and 81.2%, respectively, and 92.3% and 86.6%, respectively, for the non-dense group. No significant differences were observed in the sensitivity (p = 1.0) or specificity (p = 0.18) between these groups. The NPV was 99.3% and 99.1% in non-dense and dense groups, respectively. Unlike imaging, Videssa® Breast does not appear to be impacted by breast density; it can effectively detect breast cancer in women with dense and non-dense breasts alike. Thus, Videssa® Breast provides a powerful tool for healthcare providers when women with dense breasts present with challenging imaging findings. In addition, Videssa® Breast provides assurance to women with dense breasts that they do not have breast cancer, reducing further anxiety in this higher risk patient population.

Authors
David E Reese, Meredith C Henderson, Michael Silver, Rao Mulpuri, Elias Letsios, Quynh Tran, Judith K Wo

Provista Diagnostics material
PLOS One abstract


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