Provista Diagnostics recently reported promising data on its blood-based diagnostic test, Videssa Breast, to aid in the detection of breast cancer, even in women with dense breasts. The results were presented at the recent 15th Human Proteome Organization World Congress, held in Taipei, Taiwan, by the company’s president and chief executive officer, David Reese.
“We are excited for the opportunity to present on Provista’s serum-based combinatorial proteomic biomarker assay, called Videssa Breast,” said Reese in a recent press release. “Particularly because the test results are unaffected by dense breast tissue, this assay is an important advancement in proteomic technologies for addressing the many challenges clinicians face in detecting breast cancer in their patients.”
Women with dense breasts, or those with abnormal or difficult-to-interpret mammography results, can face difficult decisions on whether to proceed with additional imaging or biopsy.
Provista’s data suggests that Videssa Breast can help by accurately detecting the presence of breast cancer with a simple blood draw.
The test detects breast cancer, rather than assessing a patient’s risk for developing cancer, by identifying breast cancer biomarkers. The combination of this proteomic approach with traditional imaging adds biochemical evidence, allowing for improved diagnostic accuracy and greater confidence in clinical decision-making, potentially decreasing the rate of false positive and false negative results.
In his presentation, Reese highlighted the results of a recent study, in which the performance of Videssa Breast test was not affected by increased breast density in women. This effect had already been observed in women ages 25 to 50, but the study confirmed those results in women who are mostly post-menopausal (ages 50 – 75).
In both groups of women, detecting breast cancer can be difficult because breast density “masks” the cancer from detection. In such cases, women with extremely dense breasts face a worse prognosis when breast imaging does eventually find the tumor.
The diagnostic accuracy of Videssa Breast was evaluated in Provista 002 (NCT02078570), a prospective, blinded, multi-center study. The trial enrolled 1,005 patients, randomized into either validation or training groups. Results revealed that the test has a highly accurate detection of early breast cancers, independent of breast density status. This was observed regardless of variations in sample source, including the age, race, geography or clinical history of the patient or clinical trial site.
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