On September 27, 2024, AIVIS Inc. announced that it has received in vitro diagnostic (IVD) medical device certification from the Ministry of Food and Drug Safety (MFDS) for its AI-driven pathological image analysis software, Qanti IHC, designed for quantifying IHC-stained pathology slides.

Qanti IHC is a Class II diagnostic software that assists pathologists by accurately quantifying cells in digital pathology images. Developed with proprietary algorithms, the software enables biomarker-specific analysis for ER, PR, HER2, and Ki-67, providing tailored and quantitative insights based on each staining method. In addition, with its capability to detect HER2 staining at the single-cell level, the software offers a significant advantage in identifying HER2-ultralow cases.

Designed to enhance pathologist workflow, Qanti IHC significantly improves diagnostic accuracy and inter-observer consistency. By automating cell quantification, especially in high-cell-density samples, it helps reduce the manual burden and variability often associated with traditional slide interpretation.

AIVIS emphasized the product’s particular strength in detecting HER2-low and HER2-ultralow expression levels—a growing focus area in precision medicine. While conventional solutions often limit analysis to HER2-positive (3+) patients, Qanti IHC enables precise identification of HER2-low (1+, 2+) and ultra-low expression levels. This capability has sparked interest from global pharmaceutical companies and positions AIVIS for future collaboration in the era of targeted therapies like Enhertu. The company is currently preparing for clinical trials in partnership with leading hospitals in South Korea to further validate the product’s performance in clinical settings.

The company also announced that Qanti IHC is developed under a robust quality management system, having obtained both Good Manufacturing Practice (GMP) certification and ISO 13485 compliance for the development and production of IVD devices.

Dae-hong Lee, CEO of AIVIS, stated:

“With this regulatory approval, we are moving forward with technology licensing agreements with global digital pathology scanner manufacturers and conducting multiple proof-of-concept studies with hospitals and research institutions. Our mission is to support cancer diagnostics with precision AI tools that expand access to accurate and personalized care.”

About AIVIS

AIVIS is a South Korea-based medical AI company driving innovation in digital pathology. Its flagship solution, Qanti IHC, provides automated quantification of key biomarkers—including ER, PR, HER2, and Ki-67—with exceptional capability in detecting HER2-low and ultralow cases. Backed by MFDS approval and a growing global presence, AIVIS is dedicated to advancing diagnostic accuracy and enabling AI-powered precision medicine worldwide.