Imagio, Seno Medical Instruments’ non-invasive and radiation-free breast imaging technology, has been approved for commercialization by the Center for Devices and Radiological Health, part of the U.S. Food and Drug Administration (FDA).
The technology — known fully as the Imagio Breast Imaging System — was designed to help physicians better distinguish malignant, or cancerous breast tumors from benign ones.
“We are thrilled to have reached this milestone and are looking forward to moving our technology platform forward in the U.S. with this FDA approval,” Tom Umbel, Seno’s CEO, said in a press release.
Current breast imaging systems help to detect masses that may be potentially malignant, a status that can be subsequently confirmed through a breast biopsy. However, many biopsies come back negative, meaning that the previous diagnostic tests gave a false-positive result.
Such false-positive results lead to an unnecessary invasive procedure and to added stress to the patient.
Moreover, breast biopsy procedures caused by these false-positives imaging results are estimated to cost the U.S. healthcare system more than $2 billion per year in unnecessary expense.
The Imagio system aims to improve breast cancer diagnoses and to reduce the number of unnecessary biopsies by providing, in real time, not only structural or anatomical information — as most diagnostic imaging systems do — but also key functional information on the suspicious breast masses.
Importantly, it does so without the use of radiation or the need for injectable contrast agents, thereby reducing patients’ exposure to any potentially harmful aspects of imaging.
Based on Seno’s opto-acoustic ultrasound (OA/US) technology, Imagio provides high-resolution, high-contrast images of tissue anatomy and the blood flow and oxygenation in and around the mass of interest.
Malignant tumors commonly exhibit a high density of newly formed blood vessels that help their growth and nutrition, as well as a reduction in blood oxygen levels. That reduction is due to oxygen being rapidly taken by tumor cells. Neither of these conditions occurs in benign tumors.
The Imagio system also includes an artificial intelligence software, called SenoGram, to help trained and certified healthcare providers estimate the probability of malignance and differentiate between malignant and benign breast lesions.
“Our internal team and our faithful investigators and clinical trial sites have worked diligently to bring Imagio to market and improve care for patients and providers with the precise diagnostic capabilities and enhanced decision-making support that our novel [imaging system] provides,” Umbel said.
The FDA approval was based on data from the pivotal PIONEER Phase 3 clinical trial (NCT01943916), which involved more than 2,100 adult women with a suspicious breast mass. Its findings served as the basis for Seno’s premarket approval application (PMA) to the regulatory agency.
PIONEER was designed to measure Imagio’s sensitivity — the percentage of malignant tumors being correctly identified — against traditional ultrasound imaging in breast lesions. It also evaluated Imagio’s specificity, or the percentage of benign masses being correctly ruled out, also as compared with traditional ultrasound imaging.
Participants, recruited at 16 leading hospitals and imaging centers across the U.S., underwent a traditional ultrasound and an Imagio scan.
Mammography and traditional ultrasound data were used to determine if the woman should have a biopsy, while the Imagio results were later interpreted by an independent reader panel. Women who were not advised to undergo a biopsy were re-evaluated one year later to confirm the results as a true negative.
“Optimizing the diagnosis of breast masses requires a combination of very high sensitivity (≥98%) while simultaneously maximizing specificity and minimizing false positives and biopsies of benign masses,” said A. Thomas Stavros, MD, Seno’s chief medical officer.
While other imaging systems have reported improvements in specificity, “these have often come at the expense of the desired high ≥98% sensitivity,” Stavros said.
“The data from the PMA study shows that OA/US [the Imagio system] successfully achieved improved specificity at a fixed sensitivity of 98%, [the point at which] clinical decisions about whether or not to biopsy a mass are actually made.”
Imagio was cleared for use in the European Union in 2014.