“Our SoftVue System delivers a breakthrough in tissue characterization and improves the ability to find cancers in dense breast patients. It will be a game changer that will transform clinical practice with a fundamentally new, and highly impactful approach,” said Mark J. Forchette, president and chief executive officer at Delphinus. “The SoftVue PMA approval opens the door to a technological advance in dense breast screening that will help physicians save lives.”
Mammography alone misses about half the cancers in women with dense breasts. The lower sensitivity of mammography in women with dense breast tissue coupled with their substantially increased risk of breast cancer clearly demonstrates the need for additional screening approaches to detect the mammographically occult cancers. Those with Breast Imaging Reporting and Database System (BI-RADS) density categories c (heterogeneously dense) and d (extremely dense) have a four-fold increased risk for developing breast cancer. Forty percent of women in the U.S. have dense breast tissue, so that increased risk, combined with decreased sensitivity, creates a significant challenge for this population. It has become such an obvious public health issue that there is now a federal mandate to inform women if they have dense breasts after every mammogram.
Delphinus executed a Prospective Case Collection (PCC) study that served as the image database for the cancer and non-cancer cases that were subsequently used in a series of multi-reader, multi-case (MRMC) studies conducted by the University of Chicago. The PCC initiative began in the summer of 2017 and ultimately enrolled more than 8,500 asymptomatic patients in c or d density categories at 10 leading breast imaging centers around the US. A team of radiologists analyzed more than three million coronal plane images generated by the initiative.
The pivotal MRMC demonstrated that SoftVue detects and distinguishes between normal (BI-RADS 1 and 2) and abnormal (BI-RADS 3 and 4) lesions with an increase in both sensitivity of 20% and specificity of 8%, as compared to FFDM alone. Additionally, 95% of patients surveyed after their SoftVue exam indicated that they would recommend SoftVue to other women.
“With the FDA approval of SoftVue, we now have a critical new imaging tool for screening women with dense breasts to enable the earlier detection of breast cancer,” said Dr. Mary Yamashita, lead investigator of the SoftVue PCC clinical trial and Clinical Associate Professor of Radiology at Keck School of Medicine, University of Southern California, Los Angeles. “We have immense gratitude for the patients and their families, clinicians and technologists that worked so hard to make this rigorous study a success. We have expanded the tools available for breast cancer diagnosis, particularly in a population of women most in need of this technology.”
