Artist’s rendering of measurable biomarkers released from a breast cancer tumor.
courtesy: Provista Diagnostics.
ProvistaDiagnostics, Inc. has developed the Videssa Breast blood test, the first blood-based proteomic test of its kind to provide early and accurate detection of breast cancer (BC). It is specifically useful in ambiguous clinical situation when women present with difficult to interpret imaging findings.
At present imaging [including mammography, ultrasound (US), magnetic resonance imaging (MRI), and 3-D tomosynthesis] is the gold standard for BC detection. But sometimes breast density, prior biopsy or lesion size can confound the diagnosis. The physician faces a diagnostic dilemma about whether to go for a biopsy or wait further for reimaging after 6 months.
These imaging results usually fall in the Breast Imaging-Reporting and Data System [BI-RADS] categories 3 or 4.
he e-book BREAST CANCER DETECTION can be downloaded here.
The diagnostic test use ELISA to evaluates 11 serum protein biomarkers and 33 tumor-associated autoantibodies. The Videssa Breast blood test has been studied in two prospective, randomized clinical trials, Provista-001 and Provista-002, across 13 domestic clinical sites.
A total of 545 women, ages 25-50, with BI-RADS categories 3 or 4 underwent the blood test. The study results showed a BC prevalence of nearly 6%. It has a very high negative predictive value (NPV) of 99.1 %, that means the clinician can quite accurately identify those patients who are unlikely to have BC after an ambiguous imaging result.
The test has positive predictive value (PPV) of 25.2%, which means it increases the number of breast biopsies that yield a positive BC diagnosis from 1 in 11 for imaging to 1 in 4.
Overall, when used prospectively along with imaging, Videssa Breast reduceds unnecessary biopsies by up to 67%, compared with standard imaging modalities (p < 0.0001).
The authors concluded “Therefore, this study supports the use of Videssa® Breast, concomitant with imaging, to help guide the management of women under the age of 50 with challenging imaging findings.”
“With about 1.6 million breast biopsies performed each year,1 the implications of a blood test that can help clinicians confidently rule out breast cancer and avoid a potentially unnecessary biopsy are tremendous,” said Judith K. Wolf, MD, Chief Medical Officer of Provista Diagnostics, Inc
The study was published in journal of Clinical Breast Cancer: A Non-Invasive Blood-Based Combinatorial Proteomic BiomarkerAssay to Detect Breast Cancer in Women Under the Age of 50 Years.