Women with a Breast Imaging Reporting and Data System (BI-RADS) mammogram score of 3 or 4 often pose a diagnostic and management conundrum for radiologists. These women fall into a gray diagnostic zone where the subjective nature of image analysis can prevent a definitive diagnosis, and patients often wait for reimaging in six months, during which time some may have progression of invasive breast cancer and some with benign lesions face a nervous waiting game. Provista Diagnostics (New York City) is developing a comprehensive proteomic panel that can better differentiate benign lesions from invasive breast cancer, in conjunction with standard imaging. “In lay terms, BI-RADS 3 is ‘most likely benign’ and BI-RADS 4 is ‘possibly malignant,’ and most BI-RADS 3s are sent away to re-examine in six months. But, 1 percent to 2 percent sent away will actually have invasive breast cancer,” David Reese, Ph.D., Provista’s CEO tells DTET. “This is problematic for radiologists, with 40 percent of medical malpractice suits for breast cancer radiologists resulting from the BI-RADS 3-4 juncture. We hope to give radiologists a way to go home and know that their nos are actually nos.” The company recently presented results of a randomized trial of 351 […]
Women with a Breast Imaging Reporting and Data System (BI-RADS) mammogram score of 3 or 4 often pose a diagnostic and management conundrum for radiologists.
These women fall into a gray diagnostic zone where the subjective nature of image analysis can prevent a definitive diagnosis, and patients often wait for reimaging in six months, during which time some may have progression of invasive breast cancer and some with benign lesions face a nervous waiting game. Provista Diagnostics (New York City) is developing a comprehensive proteomic panel that can better differentiate benign lesions from invasive breast cancer, in conjunction with standard imaging.
“In lay terms, BI-RADS 3 is ‘most likely benign’ and BI-RADS 4 is ‘possibly malignant,’ and most BI-RADS 3s are sent away to re-examine in six months. But, 1 percent to 2 percent sent away will actually have invasive breast cancer,” David Reese, Ph.D., Provista’s CEO tells DTET. “This is problematic for radiologists, with 40 percent of medical malpractice suits for breast cancer radiologists resulting from the BI-RADS 3-4 juncture. We hope to give radiologists a way to go home and know that their nos are actually nos.”
The company recently presented results of a randomized trial of 351 women under the age of 50 with suspicious mammograms (scored as either BI-RADS 3 or 4) at the San Antonio Breast Cancer Symposium (Texas; Dec. 9-13). In a multisite trial the Videssa Breast panel of 20-plus biomarkers (equal numbers of serum protein biomarkers and tumor-associated autoantibody markers) was used in conjunction with standard imaging and improved differentiation of benign from cancerous lesions.
“We believe our proteomics approach, which combines the sensitivity of autoantibodies with the specificity of known serum protein biomarkers along with standard-of-care imaging, may reduce the number of missed actionable breast cancers, while avoiding the stress and added diagnostic costs of false negative reports,” says Reese. “For BI-RADS 4 cases, one in eight biopsies will find a tumor. If we can modestly drop that to two or three in eight, or even better, we think there is terrific health economic argument for the utility of the test.”
Unlike progress made in other areas of cancer, definitive biomarkers for breast cancer diagnosis are lacking. But Reese believes in the future “integrated” models of breast cancer diagnosis and management will incorporate protein and genetic markers, as well as imaging modalities.
The company will make the Videssa Breast commercially available in the first half of 2015, initially as a laboratory-developed test in its Scottsdale, Ariz., College of American Pathologists-accredited CLIA-compliant laboratory, while it works toward U.S. Food and Drug Administration clearance of the assay. Reese says that while the company is not yet ready to disclose final pricing, it will be in the “hundreds, not thousands” of dollars. Still, the potential market is large, with millions of women diagnosed with a BI-RADS 3 or 4 score each year.
Takeaway: Provista aims to improve breast cancer diagnosis for patients in whom conventional imaging is nondefinitive by incorporating a comprehensive proteomic panel into clinical decisionmaking and patient management.
