Ibex Medical Analytics Announces IVDR Certification for HER2 Biomarker Scoring Solution in Breast Cancer

Ibex Medical Analytics, a leader in artificial intelligence (AI)-powered cancer diagnostics, today announced it has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for its HER2 breast cancer biomarker scoring solution. Ibex’s fully automated “zero-click” AI-enhanced decision support tool for pathologists efficiently increases the accuracy and consistency of HER2 immunohistochemistry (IHC) scoring, including HER2-low cases. Ibex’s breast HER2 solution was developed and validated by Ibex in collaboration with AstraZeneca and Daiichi Sankyo.

Using digitized images of HER2 IHC stained breast cancer samples, Ibex’s breast HER2 solution detects invasive tumor cell staining patterns and classifies HER2 expression into four standard scores: 0, 1+, 2+ and 3+ (based on ASCO/CAP guidelines). It can assist pathologists in the detection and interpretation of cases with HER2 ultralow expression (defined as IHC 0 with membrane staining present). The AI-powered computational tool automates and optimizes case review with:

• “Zero-click” invasive tumor detection (automatically excluding ductal carcinoma in situ)

• Automated tumor cell identification and cell staining pattern classification

• Editable invasive contours and score recalculation

• Visualization of AI findings and cell staining pattern percentages for better understanding of score result

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