Clinical trial procedures to proceed with Korea University Anam Hospital and Ilsan CHA Hospital

AIDOT announced on the 9th that the clinical trial plan for “Cerviray”, its AI-based cervical cancer screening solution, has been approved by the Ministry of Food and Drug Safety (MFDS) as Class 3 medical imaging detection software.

Following approval of the clinical trial plan, the company will move forward in earnest with clinical trial procedures together with the team led by Professor Song Jae-yoon at Korea University Anam Hospital and the team led by Professor Kim Seong-min at Ilsan CHA Hospital.

Park Min-chan, head of AIDOT’s research institute, said that unlike other domestic AI imaging screening solutions, AIDOT’s Cerviray is not limited to ▲simply classifying normal, atypical, low-grade lesions, and high-grade lesions, or ▲recognizing acetowhite epithelium, mosaic patterns, and atypical vessels. Instead, he explained, it integrates each patient’s lesion texture, shape, and location, and—through standardization technology—has been advanced into a more finely detailed interpretation model that aligns with World Health Organization (WHO) criteria.

He emphasized in particular that, in the case of low-grade lesions, even small lesions that have a high likelihood of being missed by the naked eye can have their location detected by the AI within a 3% margin of error. He added that AIDOT “transplanted into the AI the same diagnostic process in which clinical professors make a comprehensive judgment based on decades of experience—even using these small lesions as evidence,” and said, “This clinical-trial statistical procedure will be the only AI-based imaging interpretation clinical trial of its kind in Korea.”

Park also said that by defining the clinical statistical procedure from the standpoint of global competitiveness, he expects the solution’s credibility to be further strengthened not only in Korea but also overseas.

He added that AIDOT has already secured international standard certifications including ISO 13485 and ISO 9001, as well as European CE certification. He said that once domestic MFDS certification is completed, the company will be able to provide credibility to countries that require Korean MFDS clinical results, and that it plans to complete entry into the global market without delay by having the solution validated in certification processes currently under discussion in Japan, North America, and Europe.

Published: July 9, 2021 / MedicalToday / Reporter Lee Dae-hyeon