Videssa Breast Blood Diagnostic Test: An innovative, non-invasive tool to rule out breast cancer.

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.

Provista Diagnostic home page.

Link to VIDESSA BREAST: FACT SHEET for healthcare providers. 



Videssa Breast | Blood-Based Breast Cancer Detection

Test strips for point of care detection of cervical cancer: Reality in near future.

A prototype of  test strip that could be used for the early detection of cervical cancer.
(Credit: Purdue Research Foundation photo/Curt Slyder)

Researchers at Purdue are developing technology that could enable us to detect cervical cancer with low-cost, easy-to-use, lateral flow test strips that are very similar to home pregnancy tests.

Joseph Irudayaraj, professor of biological engineering in Purdue’s School of Agricultural and Biological Engineering “This field really needs an additional way to test for cervical cancer. A test that can report cervical cancer right away is very instrumental in a lot of low- and middle-income countries where women often get HPV tests and then never come back. In higher-income countries, it’s important that anything beyond HPV tests have the ability to complement those tests.”

The technology developed by Purdue researchers works on the basis of color change of the strip that is visible to naked eye within 15-20 minutes because of reaction with proteins that are specific for cervical cancer.

Using proteomics and bioinformatics, researchers have identified valosin-containing protein (VCP) that are expressed differentially between normal specimens and those with cervical intra-epithelial neoplasia grade 2/3 (CIN2/CIN3+) or worse.

VCP-specific immunohistochemical staining (validated by a point-of-care technology) provided sensitive (93%) and specific (88%) identification of CIN2/CIN3+ and may serve as a critical biomarker for cervical-cancer screening.

The paper was published earlier in April 2016 in Journal of Oncotarget .

Combining proteomics and lateral-flow immunochromatography (LFIC) technology the researchers have formulated a simple point of care test for cervical cancer screening that can be used in low- and middle-income countries (LMICs).

Pap cytology followed by further evaluation using HPV DNA/ colposcopy and biopsy for abnormal cytology test is the current screening test for detecting cervical cancer. This multistep process that depends on recall system is not sustainable in LMICs.

About 84% of cervical cancer cases occur in low- and middle-income countries, where it is still diagnosed at very late stage leading to high morbidity and mortality according to the World Cancer Research Fund International.

Researchers have already documented the proof of concept are working on the early prototype for the technology, and improving sensitivity and specificity.

“We’re working to greatly improve the detection limit of our testing,” said Wen Ren, a Purdue postdoctoral researcher working with Irudayaraj. “That will make it much easier to detect cervical cancer based on a very low amount of markers in smaller samples.”

Additional work is also underway to develop the test for additional samples like cervical lavage specimens, PreservCyt specimens and cervical swabs.

Larger studies are needed for robust clinical validation and commercialization of the test.

The technology could be of use to detect other diseases in future including pathogens of infectious disease.