GE HealthCare marks Korean approval of Omnipaque for contrast-enhanced mammography

GE HealthCare Korea held a press conference to commemorate the approval of the contrast agent Omnipaque (ingredient: iohexol) for use in contrast-enhanced mammography (CEM).

During the conference, Professor Shin Hee-jung of the Department of Radiology at Asan Medical Center introduced the potential changes CEM could bring to breast cancer diagnosis.

"CEM is a game-changer in breast cancer diagnostics," Shin said. "It combines the accessibility of mammography with the enhanced visibility of MRI, offering a powerful new tool in our diagnostic arsenal."

CEM offers several advantages over traditional mammography and MRI, while showing no significant difference in specificity and overall diagnostic performance.

"In our studies, we've found that CEM can detect small lesions that might be missed by standard mammography, especially in dense breast tissue,” she said. “This could lead to earlier detection and potentially better outcomes for patients."

According to Shin, CEM can be completed within 10 minutes, including contrast agent injection, and is estimated to cost 3-4 times less than MRI in tertiary hospitals.

“CEM's lower cost and smaller equipment size could lead to wider adoption,” she said. "The efficiency and cost-effectiveness of CEM are major advantages as we can potentially screen more patients in less time, which is crucial for early detection."

The introduction of CEM is particularly significant for Korea, where an estimated 80 percent of women have dense breast tissue.

Standard mammography has limitations for dense breasts, with sensitivity dropping to as low as 50 percent, according to Shin. Given that eight out of 10 Korean women have dense breasts, CEM could become a crucial diagnostic option, she added.

Recent studies have demonstrated CEM's efficacy. In a study of 130 breast cancer patients with dense breasts, CEM showed a sensitivity of 96.5 percent compared to 75.6 percent for standard digital mammography.

Another study comparing CEM to MRI in 235 breast cancer patients found equal sensitivity (91.5 percent) and slightly higher specificity for CEM (89.5 percent vs. 80.2 percent).

The adoption of CEM could also help alleviate the current strain on MRI services in major hospitals.

Shin stressed that many university hospitals are running their MRI facilities 24 hours a day and still can't keep up with demand.

The potential for CEM to be available in smaller clinics and hospitals is also exciting as it could bring advanced diagnostic capabilities closer to patients, regardless of their location, she added.

As CEM gains recognition, it is being incorporated into international guidelines. Both the American College of Radiology (ACR) and the National Comprehensive Cancer Network (NCCN) now recommend CEM as an alternative when MRI is not feasible.

With the approval of Omnipaque for CEM use in Korea—the first such approval in Asia—Shin expressed optimism about the technique's potential to improve breast cancer diagnosis and ultimately, patient outcomes.

"This approval marks a significant milestone in breast cancer diagnostics in Korea,” she said. "As we continue to research and expand the indications for CEM, I believe we'll see a positive impact on early detection rates and, consequently, on patient survival and quality of life."