FDA Clears Epredia’s E1000 Dx Digital Pathology Solution

PHC Holdings Corporation subsidiary Epredia has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its E1000 Dx Digital Pathology Solution (E1000 Dx). Touted as a high-speed, automated, whole-slide imaging digital scanner with medical grade viewer, advanced image management, viewer software, the E1000 Dx creates high-resolution digital images of up to 1,500 tissue samples daily.

Epredia’s solution allows laboratories to maximize throughput and streamline cancer diagnostics. With the FDA clearance, Epredia adds clinical use to its portfolio of digital pathology technology, which potentially can make diagnostics more efficient and accurate.

As cancer cases increase, pathology laboratories are under pressure to accelerate 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,” Epredia Chief Strategy Officer Balazs Liposits said. “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 United States 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 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, United Kingdom, which is the country’s only manufacturer of high throughput digital pathology equipment.

Epredia is a global leader in the anatomical pathology field, providing 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 roughly 1,200 employees.

PHC Holdings Corporation is a global collection of healthcare companies with subsidiaries (referred to collectively as PHC Group) that 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 FY23 were JPY 353.9 billion with global distribution of products and services in more than 125 countries and regions.