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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.
 |
| e-book by Provista. |
The
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.
Link to
VIDESSA BREAST: FACT SHEET for healthcare providers.
Videssa Breast | Blood-Based Breast Cancer Detection
Videssa Breast | Blood-Based Breast Cancer Detection
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