Study Demonstrates Superiority of Delphinus’s Ultrasound Tomography System, SoftVue, in Conjunction with Mammography for Breast Cancer Screening in Women with Dense Breasts
July 01 2024 - 7:05AM
Business Wire
Now published in Radiology, results are based
on a comparison with screening for breast cancer using mammography
alone
Delphinus Medical Technologies, a pioneering medical imaging
company that developed the SoftVue™ Breast Ultrasound Tomography
(UST), announced today the publication of a study comparing
mammography in conjunction with SoftVue UST vs mammography alone in
women with dense breasts. The study concluded that in women with
dense breasts, mammography plus SoftVue UST improved cancer
detection by radiologists versus mammography alone. The article
“Comparison of Mammography and Mammography with Supplemental
Whole-Breast US Tomography for Cancer Detection in Patients with
Dense Breasts” has been published in the peer-reviewed journal,
Radiology.
“This study demonstrates the benefits of supplemental ultrasound
tomography screening for women with dense breasts,” said Dr.
Mary Yamashita, Section Chief of Breast Imaging and Clinical
Professor of Radiology and Surgery at the University of Southern
California, Keck School of Medicine. “Our findings revealed an
increase in cancer detection and a significant improvement in
BIRADS 3 specificity when SoftVue UST was used alongside
mammography. The enhanced specificity can empower radiologists to
better differentiate benign masses (BIRADS 2), ultimately reducing
the need for short-term follow-ups for our patients.”
Among 140 cases included in the multi-reader, multi-case study,
mammogram plus SoftVue UST demonstrated superiority in cancer
detection compared to mammography alone. Thirty-two Mammography
Quality Standards Act-qualified radiologists from academic,
private, and community-based practices in diverse areas
participated in the study. For each case, readers independently
evaluated the mammogram and assigned a Breast Imaging Reporting and
Data System (BI-RADS) score. They then assessed the mammogram plus
UST for the same case and assigned a separate BIRADS
assessment.
The authors concluded:
- Adding SoftVue UST to screening mammography showed
statistical superiority in the performance of breast cancer
detection in women with dense breasts compared with mammography
alone.
- Adding SoftVue UST to screening mammography led to a
statistically significant 25% improvement in sensitivity for
breast cancer detection of BI-RADS 4 or higher lesions compared
with mammography alone.
- Adding SoftVue UST to screening mammography led to a
statistically significant 8% improvement in specificity for
BI-RADS 3 lesions compared with mammography alone.
“SoftVue provides a unique solution that has been missing in
dense breast screening. As a breast imager it is exciting to see a
screening technology that not only increases cancer detection, but
also allows us to reduce the number of short-term follow-ups. This
means more women who have breast cancer will be referred for biopsy
immediately and more women without breast cancer will be reassured
they do not need follow-up,” said Dr. Elise Berman, Medical
Director, Delphinus Medical Technologies.
Breast cancer screening with mammography reduces mortality by
41% in women with non-dense breasts but reduces mortality by only
13% in women with dense breasts. The U.S. government has also
reinforced the importance of supplemental screening by mandating
federal breast density notifications to be sent to each affected
patient, effective September 2024.
SoftVue UST paired with mammography provides a new annual
screening solution for women with dense breasts and is the only
ultrasound-based breast imaging system that is FDA-approved for
same-day screening as mammography.
About Delphinus Medical Technologies, Inc.
Headquartered in Novi, Michigan, Delphinus Medical Technologies,
Inc., is a pioneering medical imaging company that developed
SoftVue™, featuring the first circular array transducer technology.
The patented technology is a 3D whole-breast ultrasound tomography
system that delivers no radiation, requires no compression, and
images the entire breast with a single scan. To learn more, visit
our website and follow us on LinkedIn.
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Sam Choinski Pazanga Health Communications
schoinski@pazangahealth.com (860) 301-5058