Study results showed that combining Videssa® Breast with imaging improves breast cancer detection and significantly reduces the total number of biopsies in patients with abnormal imaging findings. Results below are from two prospective clinical trials, which examined women ages 25 to 75 with a BI-RADS 3, 4 or 5 assessment.
Videssa Breast would have reduced the total number of biopsies by 45 percent.
Key Findings from Two Rigorous Clinical Trials
Performance of Videssa Test
Videssa Breast accurately detects the presence or absence of breast cancer in women ages 25 to 75 with
high sensitivity (93.3%), specificity (63.8%),
negative predictive value (NPV) (98.4%) and positive predictive value (PPV) (34.0%).
General Findings
Combining Videssa Breast with diagnostic imaging detected 100 percent of breast cancers.
Breast density did not affect the performance of Videssa Breast.
NPV over 98 percent = less than 2 percent probability of breast cancer in patient with a low protein signature test result.
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Clinical Trial Design
Provista has conducted two prospectively collected, randomized, blinded, multi-center clinical trials, which enrolled patients from 15 sites across the US to evaluate the ability of Videssa Breast to detect the presence or absence of breast cancer in patients with abnormal imaging findings.
Provista 001 Trial enrolled 351 women ages 25 to 49 with a BI-RADS 3 or 4 assessment on imaging and who were followed for six months. Women with a previous history of breast cancer or breast biopsy were excluded from the study
Provista 002 Trial enrolled two cohorts totaling 1005 women ages 25 to 75. Women with a history of breast cancer or biopsy within six months were excluded from the study
Provista 002 Cohort 1 enrolled 501 women with a BI-RADS 3 or 4 assessment on imaging and who were followed for six months
Provista 002 Cohort 2 enrolled 504 women with a BI-RADS 3, 4 or 5 and who were followed for six and 12 months
