Radiologists consider breast density detected in digital mammograms to be a key factor when evaluating the likelihood of a woman developing breast cancer. Women with dense breasts are at four-to-six times greater risk of developing breast cancer than women with fatty breasts. This is due to the fact that cancer grows in dense tissue and cancerous tumours are harder to detect visually on a standard mammogram when the breast is composed of dense tissue.
Radiologists currently visually evaluate mammograms to classify breast density according to four broad BIRADS levels established by the American College of Radiology (ACR). However, the ACR has now indicated that radiologists’ visual assessments using the BIRADS lexicon are not reliably reproducible.
To address this measurement problem, Mo Abdolell, Associate Professor in the Dept. of Diagnostic Radiology at Dalhousie University in Halifax, and President and Founder of Densitas Inc., set out to develop a robust tool to more precisely and reliably measure breast density from digital mammograms.
He has developed a way to generate standardized, precise and reliably reproducible breast density measurements using a fully automated algorithm that processes digital mammograms. Study results confirm that the Densitas algorithm generates breast density measurements that are in excellent agreement with radiologists’ breast density assessments of full-field digital mammography images.
Delivering automated breast density scores promises to improve women’s health outcomes by providing key information that is considered when deciding how best to triage women for appropriate diagnostic procedures and when establishing follow-up screening protocols.
Need or Opportunity:
Densitas Inc. is the company Abdolell formed to commercialize his discovery. He had never commercialized an innovation before and quickly became aware that the product development and commercialization process is complex. Recognizing that he needed help navigating his way through the process, he partnered with CIMTEC to embark on this journey.
The company’s needs have evolved from validation to include design, technology development and business development advice and services, all of which he’s been able to access at CIMTEC.
In helping Densitas understand how to think about its design requirements, CIMTEC has been able to work with Densitas to develop and validate a robust prototype algorithm according to the specific requirements associated with functionality, publication and marketability to investors.
CIMTEC continues to work with Densitas. As the project has progressed, our involvement has expanded to further support Densitas on its path to commercialization. The complexity involved in developing a medical imaging device has led to CIMTEC providing design, development and validation of a robust prototype algorithm; options to integrate the algorithm into clinical workflow; business development services; and advice on new strategic partnerships.
CIMTEC’s relationship with Densitas has grown into a collaborative effort that demonstrates key value to potential investors.
Our support on the many activities listed above has helped Densitas meet its milestones. Achieving its milestones has enabled the company to secure additional funds from the Industrial Research Assistance Program (IRAP) and the Atlantic Canada Opportunities Agency (ACOA). As a result, in the late fall of 2013, Densitas opened an office in Halifax and added several employees to push toward finalizing the first commercial prototype of its algorithm.
Around the beginning of 2016, Densitas received the CE Mark from the European Commission and a medical device license from Health Canada for its flagship product, DM-Density. DM-Density is Densitas’ first commercial product and is an invaluable tool that radiologists use when reviewing a woman’s mammogram to assess breast density. Accurately assessing breast density is an important part of the mammography process, as dense breasts have a higher risk of developing breast cancer. Densitas was also recognized as one of 2016’s “best and brightest in medical imaging” (2016 Minnie’s Best New Radiology Software). The process is underway for FDA clearance for DM-Density.