Epredia Receives U.S. FDA 510(K) Clearance for the E1000 Dx™ Digital Pathology Solution Designed to Improve Laboratory Workflow in Cancer Diagnostics
Innovative technology digitizes up to 1,500 tissue samples daily, supporting quick and accurate diagnosis by pathologists
March 4, 2025
Epredia, a global leader in precision cancer diagnostics and subsidiary of PHC Holdings Corporation (TSE: 6523), today announced U.S. Food and Drug Administration (FDA) 510(K) clearance for its E1000 Dx Digital Pathology Solution (E1000 Dx). The E1000 Dx consists of a high-speed, automated, whole-slide imaging digital scanner with medical grade viewer and advanced image management and viewer software that creates high-resolution digital images of up to 1,500 tissue samples daily. This can allow laboratories to maximize throughput and streamline cancer diagnostics. With this clearance, Epredia adds clinical use to its portfolio of digital pathology technology, which has the potential to make diagnostics more efficient and accurate.
As cancer cases increase, pathology laboratories are under pressure to speed up processes and reduce costs. The E1000 Dx is designed to maximize laboratory throughput and efficiency with technology advancements in sample detection and quality control procedures. One advancement is algorithm-based sample detection, which pinpoints the location of the sample and allows for quicker scanning. Additionally, dual slide processing increases workflow efficiency by processing two slides at once. It is the first FDA-cleared digital pathology solution with a quality control feature that automatically triggers an advanced focal map rescan, if needed, to ensure high image quality for review by the pathologist. The E1000 Dx has been designed to be interoperable with other existing laboratory equipment and software.
“Digital pathology is the future of cancer diagnostics, but adoption has historically meant laboratories piecing together various hardware and software, which has caused challenges with interoperability. At Epredia, we provide precision equipment that covers the total workflow of the laboratory from accessioning to sign out. We launched the E1000 Dx to meet the needs of laboratories for throughput and quality, while also maintaining interoperability to help facilities maximize their digital pathology investment and minimize time needed from healthcare professionals.”
Epredia has offered the technology behind the E1000 Dx since 2017 for research use only in the U.S. and as an IVD instrument in Europe. In the E1000 Dx, Epredia has refined the technology and software to meet the higher quality standards for clinical use and offer a seamless workflow for laboratorians and pathologists. Now with FDA 510(K) clearance for clinical use, Epredia will bring the technology to U.S. clinical facilities for the first time, supporting patient care in addition to research. The company manufactures the E1000 Dx at its facility in Runcorn, UK, which is the only manufacturer of high throughput digital pathology equipment in the UK.
About Epredia
Epredia is a global leader in the anatomical pathology field, providing comprehensive solutions for precision cancer diagnostics and tissue diagnostics. Powered by key brands, including Erie Scientific, Menzel-Gläser, Microm, Shandon, and Richard-Allan Scientific, Epredia’s portfolio includes microscope slides, instruments and consumables. Epredia was established following the acquisition of Thermo Fisher Scientific’s Anatomical Pathology business by PHC Holdings in 2019. Epredia has operations sites in the United States, the United Kingdom, Germany, Italy, France and China with a total of around 1,200 employees. Epredia is committed to achieving its mission to improve lives by enhancing cancer diagnostics for patients around the world. For further information on Epredia and its products, please visit www.epredia.com.
About PHC Holdings Corporation (PHC Group)
PHC Holdings Corporation (TSE 6523) is a global collection of healthcare companies with a mission of contributing to the health of society through healthcare solutions that have a positive impact and improve the lives of people. Its subsidiaries (referred to collectively as PHC Group) include PHC Corporation, Epredia, Ascensia Diabetes Care, LSI Medience Corporation, Mediford, and Wemex. Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, life sciences and diagnostics. PHC Group’s consolidated net sales in FY2023 were JPY 353.9 billion with global distribution of products and services in more than 125 countries and regions. www.phchd.com
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Julia Cottrill
PHC Group Corporate Communications