It is the second patent the system has received. The first was from the United Kingdom in July 2015.
One in eight women will be diagnosed with breast cancer during their lifetime, and more than 40 percent will die of it, experts estimate. When diagnosed early, breast cancer can be successfully treated, highlighting the need for better and more accurate diagnostic tools.
Mammography has been a mainstay in breast cancer screening the past three decades. While it has saved many lives, it is unable to detect, with accuracy, early-stage breast cancer in women who have dense breasts. That condition affects nearly 40 percent of women worldwide.
Combining digital mammography with breast ultrasound, particularly 3D automated breast ultrasound, appears to increase the accurate diagnosis of early-stage breast cancer.
CapeRay has combined both imaging modes into a single device. That eliminates the need for women to have two screenings in which the breasts may be differently oriented and compressed. A single devices improves diagnostic accuracy in dense breasts, CapeRay said.
The company’s first model, named Aceso in honor of the Greek goddess of healing, requires only 10 minutes to screen a patient, versus 30 minutes when two separate imaging procedures are done. Aceso also reduces breast compression and lowers a patients’ exposure to radiation, CapeRay said.
Aceso has been successfully tested in two clinical trials whose results were published in the journals Diagnostics and Clinical Imaging. It is going through a European medical-product approval process at the moment.
“This patent not only protects Aceso, our existing product that integrates full-field digital mammography (FFDM) and automated breast ultrasound (ABUS),” Kit Vaughan, CEO of CapeRay, said in a press release. “It also protects Aegle, our future product that will combine digital breast tomosynthesis (DBT) and ABUS in one platform.”
The U.S. patent was issued under an initiative called the Patent Prosecution Highway that accelerates a member country’s review when another member has approved a patent. Sharing information between patent offices is aimed at reducing the review workload and improving the quality of the patent that is eventually granted.