Epredia, a division of PHC Holdings Corporation, and provider in precision cancer diagnostics, has received U.S. Food and Drug Administration (FDA) 510(K) clearance for its E1000 Dx Digital Pathology Solution, allowing its use in clinical settings. The E1000 Dx is an advanced digital scanner designed to create high-resolution images of up to 1,500 tissue samples per day. It features algorithm-based sample detection, dual slide processing, and a quality control system that automatically rescans images to ensure accuracy. These capabilities aim to improve laboratory efficiency and streamline cancer diagnostics as pathology labs work to meet increasing demands.
Epredia has provided digital pathology technology for research use since 2017, but this is the first time its solution has been approved for clinical use in the U.S. The E1000 Dx is designed to integrate with existing laboratory systems, helping facilities transition to digital workflows without compatibility issues. Epredia manufactures the scanner in its Runcorn, UK facility, the only manufacturer of high-throughput digital pathology equipment in the country. Company executives highlighted the importance of interoperability and efficiency in advancing cancer diagnostics, stating that the E1000 Dx will help laboratories improve accuracy while optimizing their operations.
