An artificial intelligence-based prostate cancer diagnosis aid developed by a Korean company has received marketing authorization from overseas regulators, attracting the industry’s attention.

Deep Bio said Tuesday that its AI-based prostate cancer diagnostic auxiliary software, DeepDx Prostate, received a sales license from the Swiss medicines agency (Swissmedic) on Aug. 25.

Swissmedic is responsible for approving and supervising medicines and medical devices in Switzerland. With this approval, Deep Bio will sell DeepDx Prostate in Switzerland.

DeepDx Prostate is software that aids in cancer diagnosis by using AI to analyze Whole Slide Image (WSI) images of prostate biopsy tissue stained with hematoxylin and eosin to find cancerous areas and distinguish their severity.

The analysis results are provided as Gleason pattern 3, 4, 5, Gleason score, and 5 Gleason grades according to the Gleason grading system, the most used method to classify prostate cancer tissue differentiation. It can automatically measure the proportion of cancer in the total tissue, the share of each Gleason pattern area, and the length of the tissue and cancer area to help improve the accuracy of diagnosis.

"This approval by the Swissmedic recognizes our global competitiveness as an AI-based histopathology cancer diagnostic product," Deep Bio CEO Kim Sun-woo said. “It also demonstrates Deep Bio's firm commitment to improving access to high-quality healthcare globally and advancing AI-based prostate cancer diagnostics."

Deep Bio has continued to expand its global reach through partnerships with leading digital pathology organizations in the U.S., Europe, and India. The company is collaborating with leading U.S. research institutions, including Stanford University School of Medicine and Harvard Dana-Farber Cancer Institute, and has published clinically validated studies in prestigious medical journals, such as “Cancers” and “npj Digital Medicine., according to the company.

Besides, Deep Bio signed a business agreement with GenCurix last Wednesday to jointly develop a business model for providing AI prostate cancer diagnostic tests.