Epredia Gets FDA 510(K) Clearance for E1000 Dx™ Digital Pathology Solution
Epredia, a global leader in precision cancer diagnostics and a subsidiary of PHC Holdings Corporation, announced today that it has received U.S. Food and Drug Administration (FDA) 510(K) clearance for its E1000 Dx™ Digital Pathology Solution (E1000 Dx). This new, high-speed, automated whole-slide imaging digital scanner, combined with medical-grade viewing and advanced image management software, is designed to transform cancer diagnostics by increasing efficiency and accuracy in pathology laboratories. The FDA clearance adds clinical use to the technology’s existing capabilities, enabling laboratories to handle up to 1,500 tissue samples daily, enhancing throughput while maintaining quality and precision.
The approval comes at a time when the demand for faster, more cost-effective diagnostic solutions is critical due to the growing number of cancer cases globally. Pathology laboratories are under increasing pressure to streamline processes, reduce costs, and speed up diagnostics. The E1000 Dx addresses these challenges by improving laboratory efficiency with advanced features aimed at optimizing throughput and workflow. Among its key innovations is algorithm-based sample detection, which helps identify and locate tissue samples quickly for faster scanning. Additionally, the dual slide processing feature, which allows for the simultaneous scanning of two slides, further accelerates workflow, making it the first FDA-cleared digital pathology solution to include automatic focal map rescans if image quality falls below acceptable levels.
The E1000 Dx is designed with built-in quality control features, which help ensure the consistency and accuracy of results, making it ideal for high-volume laboratories. With its advanced image management and viewing software, the system provides pathologists with clear, high-resolution digital images of tissue samples, significantly improving diagnostic accuracy. The solution’s interoperability with other laboratory equipment and software also allows for seamless integration, making it easier for healthcare facilities to adopt digital pathology solutions without having to overhaul existing infrastructure.
Balazs Liposits, Chief Strategy Officer at Epredia, emphasized the importance of this development, stating, “Digital pathology is the future of cancer diagnostics, but the adoption has often been challenging due to the need for laboratories to piece together various hardware and software. Epredia’s E1000 Dx offers precision equipment that covers the entire workflow, from accessioning to sign-out, maximizing throughput and quality while maintaining interoperability. Our goal is to help healthcare facilities optimize their digital pathology investments while reducing the time burden on healthcare professionals.”
The technology behind the E1000 Dx has been available in the U.S. for research use only since 2017, and in Europe as an in-vitro diagnostic (IVD) instrument. The FDA 510(K) clearance now enables Epredia to offer the solution to U.S. clinical facilities for the first time, expanding the technology’s use beyond research and supporting patient care. Epredia has worked to refine the E1000 Dx’s software and hardware to meet the rigorous quality standards required for clinical use. This enhancement allows laboratories to benefit from a seamless workflow, improving both the efficiency and quality of cancer diagnostics.
Epredia manufactures the E1000 Dx at its state-of-the-art facility in Runcorn, UK, which is the only facility in the country dedicated to producing high-throughput digital pathology equipment. This facility plays a critical role in ensuring the scalability and quality of the products, enabling Epredia to meet the increasing demand for digital pathology solutions in clinical settings.
The E1000 Dx represents a significant milestone in the adoption of digital pathology, which is rapidly becoming the standard of care in the cancer diagnostic field. By digitizing slides and enabling pathologists to view and analyze high-resolution images on a computer, the E1000 Dx improves accuracy, reduces diagnostic errors, and allows for faster turnaround times. This technological advancement will be instrumental in addressing the growing global cancer burden by increasing the capacity of pathology labs to handle higher volumes of samples while maintaining diagnostic quality.
About Epredia
Epredia is a leading provider of comprehensive solutions for precision cancer and tissue diagnostics. The company’s portfolio includes renowned brands such as Erie Scientific, Menzel-Gläser, Microm, Shandon, and Richard-Allan Scientific. Epredia is committed to advancing the field of anatomical pathology by providing high-quality, innovative products that enhance cancer diagnostics. After PHC Holdings acquired Thermo Fisher Scientific’s Anatomical Pathology business in 2019, Epredia was established to continue to drive excellence in cancer diagnostics. The company operates globally, with facilities in the United States, the United Kingdom, Germany, Italy, France, and China, and employs around 1,200 people. Epredia’s mission is to improve lives by advancing cancer diagnostics and supporting healthcare professionals worldwide in providing the best possible care to patients.
