Significant news published about Omnyx, the joint venture of GE Healthcare and the University of Pittsburgh Medical Center acquiring the CE Mark in the European Union. Simply stated, what is being coined the “Omnyx Integrated Digital Pathology System” allows for conversion of whole slide images from specific third party scanners with the Omnyx digital pathology system for creating, managing, storing, annotating, measuring and viewing whole slide images for routine pathology use. Great news for getting the right slide on the right patient to the right pathologist at the right time, breaking down geographic and time barriers for departmental and collaborative communication across an enterprise. For more information on the mark, implications, legalities, manufacturer responsibilities and participating countries, click here.
I think this is encouraging news for manufacturers to obtain clearance for use of whole slide images for routine pathology use in the United States. While the particular study design, scanner technologies or use cases will not be applicable to a pure simple cross validation with the FDA, there are significant lessons learned here that can be applied to safe manufacturing practices for clinical use in this country based on the Omnyx experience within Europe.
GE Healthcare has announced that the Omnyx™ Integrated Digital Pathology (IDP) system, developed in a joint venture with University of Pittsburgh Medical Center (UPMC), has acquired the CE Mark in the European Union under the ‘In Vitro Diagnostics Directive’.
This designation enables pathology professionals to use Omnyx IDP as a tool for creating, managing, storing, annotating, measuring, and viewing digital Whole Slide Images (WSI) for routine pathology use. In addition, this CE Mark includes an application to convert whole slide images from specific third party scanners for use in the Omnyx digital pathology system, which provides additional flexibility for customers.
Getting the right case, to the right pathologist, at the right time is important to help expedite accurate diagnoses. The Omnyx technology does what traditional microscopes cannot – it unites the pathology department, helping to improve collaboration, communication, and efficiency across the enterprise. By digitising slide images and corresponding workflow, Omnyx™ IDP provides pathologists with powerful digital tools to quickly assimilate, analyse, and share pathology cases and associated patient information. This helps enable efficiencies related to case review and communication with colleagues or specialists in the field, regardless of location.
The University Hospitals Coventry and Warwickshire (UHCW) NHS Trust, one of the UK’s largest teaching trusts serving a population of over a million people, took part in a successful three month beta test of the Omnyx IDP system last year. Dr David Snead, Consultant Pathologist and Clinical Director for Cellular Pathology at UHCW said: “Digital pathology primarily needs to enable pathologists to work more efficiently as part of larger teams. One of the most refreshing aspects of the Omnyx system is that it is designed to do exactly that. Through a well thought out system architecture and workflow program, Omnyx could feasibly link a number of pathology departments to work as one large team. This would help pathologists achieve great time efficiency. With efficiency, cost saving should soon follow.”
“Today, many histology departments prepare slides then walk, mail, or courier the slides over to the anatomic pathology department. A waiting pathologist examines each slide with a single microscope. Now envision a digital system that allows a group of pathologists, or a multi-disciplinary team of specialists, to receive pathology images, scanned from the histology team, within seconds, to their desktop for analysis. With the CE Mark designation, we can now make this vision a reality for more healthcare organisations in Europe,” said Olivier Croly, VP and GM GE Healthcare IT, Europe.
Explained Jim LaFrance, CEO of Omnyx: “We truly believe digital pathology will transform the practice of pathology over the next ten years. That transformation begins with creating a comfortable user environment to enable the technology transition. We put a great deal of emphasis in designing the Omnyx system to provide an exceptional experience that helps pathologists make efficient use of their time and render confident diagnoses”.
