Breast Cancer Diagnostic Blood Test Set for Imminent Availability

By LabMedica International staff writers
Posted on 15 Dec 2015

A blood test for breast cancer diagnosis in women with questionable mammographic findings and/or dense breast tissue is due for marketing release in early 2016.

Clinical data supporting the effectiveness of the Provista Diagnostics, Inc. (New York, NY, USA) Vanessa Breast assay was presented by Dr. Ana Lournco, a radiologist at Rhode Island Medical Imaging (RI, USA), in a presentation on December 3, 2015, at the 101st Scientific Assembly & Annual Meeting of the Radiological Society of North America in Chicago (RSNA; IL, USA).

Image: Videssa Breast uses a combination of multiple serum protein biomarkers, multiple tumor associated autoantibodies, patient clinical data, and a highly sensitive ELISA-based platform to deliver an accurate diagnosis (Photo courtesy of Provista Diagnostics, Inc.).

Videssa Breast is intended for use in women between the ages of 25–75 years, who have questionable mammographic finding and/or dense breast tissue. In combination with clinical and radiological evaluations, Videssa Breast was designed to accurately detect the presence or absence of invasive breast cancer/ductal carcinoma in situ (DCIS) and reduce unnecessary follow-up procedures such as further imaging and biopsies. Videssa Breast is a protein-based blood test that can accurately detect the presence or absence of breast cancer. Videssa Breast detects breast cancer, rather than assessing a patient's risk for developing cancer in the future by identifying biomarkers that are early warning signals of breast cancer.

Provista's prospective, blinded, randomized, study enrolled over 500 patients from 10 breast cancer centers across the United States and included women ages 25–75 who had a BI-RADS 3 (probably benign) or BI-RADS 4 (suspicious) finding on imaging. Data from the study demonstrated the ability of Provista's biomarker assay to accurately detect the presence or absence of invasive breast cancer and/or DCIS with high sensitivity, specificity, negative predicative value (NPV), and positive predictive value (PPV).

"Provista's technology is not only groundbreaking as a complimentary diagnostic, but is also backed by strong, prospective clinical trial data," said Dr. Lourenco. "I chose to present their findings because I wanted to ensure my fellow radiologists learned of it."

"Provista is honored to have Dr. Lourenco present our data at this year's Radiological Society of North America meeting," said Dr. David Reese, president and CEO of Provista Diagnostics. "As a participant of our clinical trials and a well-respected radiologist, Dr. Lourenco provides valuable insight and validity to our data amongst a large group of peers."

Related Links:
Provista Diagnostics, Inc.
Rhode Island Medical Imaging