AIVIS, a digital pathology company specializing in AI-powered biomarker quantification, is expanding its technology into antibody-drug conjugate (ADC) development, with a focus on biomarker analysis for patient stratification and companion diagnostic (CDx) research.

In February 2026, AIVIS entered into a joint research agreement with ADC-focused biotech AimedBio to apply Qanti® Discovery to ADC development. Built on the core technology underlying Qanti® IHC, AIVIS’s cell-level IHC analysis solution approved as a medical device by the MFDS (Korean Ministry of Food and Drug Safety), Qanti® Discovery extends the application of AIVIS’s pathology AI beyond clinical practice and into biopharmaceutical R&D.

“As ADC patient selection becomes more precise, the need for AI-powered biomarker quantification continues to grow,” AIVIS CEO Daehong Lee said at the 4th Samsung Medical Center × AimedBio ADC Conference in Seoul on August 27.

The growing need for quantitative biomarker assessment is particularly evident in HER2-targeted ADCs. Enhertu (T-DXd), developed by AstraZeneca and Daiichi Sankyo, has expanded the treatment landscape through the large-scale Phase 3 DESTINY-Breast clinical program, extending beyond HER2-positive disease to include patients with HER2-low and, more recently, HER2-ultralow expression. This expansion has placed greater emphasis on precise patient stratification across increasingly subtle levels of HER2 expression.

In particular, distinguishing HER2-ultralow cases from those with no detectable HER2 expression can be challenging through visual assessment alone, highlighting the need for more standardized and quantitative approaches to biomarker assessment.

Against this backdrop, AIVIS is extending its AI-powered biomarker quantification technology from clinical pathology into targeted therapy research, with applications spanning biomarker research, patient stratification and CDx development. The company is seeking to establish quantitative pathology as a foundation for more standardized and reproducible biomarker assessment in the development of next-generation ADCs and other biomarker-driven therapies.