Qualitopix

Qualitopix is a pathology image analysis software designed to enhance precision in pathology through the standardization of tissue biomarker staining. It leverages AI-driven quantification and monitoring to ensure the consistency of staining over time, using standardized and validated test materials.

The software addresses the high error rates in immunohistochemistry (IHC) staining, which have historically been much higher than other clinical tests, potentially leading to incorrect diagnoses. Qualitopix utilizes advanced controls and AI to measure staining intensity daily, recording these measurements in a Levey-Jennings plot to quickly identify deviations from the normal range. This function enables users to take immediate corrective actions.

Examples of detectable issues include:

• Bad reagent lot: A rise in intensity values linked to a specific reagent lot, resolved by switching lots.
• Positional inconsistencies: Dropped intensity values due to incorrect leveling in the slide rack.
• Insensitive HER2 clone: Inconsistent signal across HER2 runs, corrected using different clones.

Qualitopix supports effortless implementation with no local installation needed. Users can effortlessly incorporate the system into their workflows due to its intuitive setup and rapid turnaround. Pre-prepared cell lines with standardized biomarker expressions can be processed, scanned, and uploaded for analysis. A single-slide standalone scanner is available for those without scanning capabilities.

Users can upload images and metadata without any software installation—simply using drag and drop functionality. Within a short time post-upload, quantitative results are accessible, and alerts for tests requiring attention are provided. This feature aids in efficient troubleshooting.

Compliance with evolving regulatory demands, such as those outlined in ISO 15189:2022, is facilitated by Qualitopix's documentation tools. These tools help manage third-party control usage and maintain monitoring records for stain assays. Emerging industry discussions, such as those spurred by recent editorials demanding assay-level regulation for immunohistochemistry, indicate that further regulations may be forthcoming. Staying updated on novel markers and diagnostics is facilitated by this advanced software.