Precision cancer diagnostics firm Epredia has announced U.S. Food and Drug Administration (FDA) 510(K) clearance for its E1000 Dx digital pathology solution.
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 maximise 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.
Designed to maximise laboratory throughput and efficiency, the E1000 Dx is equipped 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.
Balazs Liposits, Epredia’s Chief Strategy Officer, said: “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 maximise their digital pathology investment and minimise time needed from healthcare professionals.”
Epredia has offered the technology behind the E1000 Dx since 2017 for research use only in the US 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 US 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.