Concordance Between Omnyx .RTS Images & Hamamatsu .NDPI Images
Research type
Research Study
Full title
Concordance Between Omnyx System with Omnyx .RTS Images and the Omnyx Dynamyx Software with Hamamatsu .NDPI Images
IRAS ID
255516
Contact name
KAYLEIGH PATTERSON
Contact email
Sponsor organisation
Inspirata, Inc.
Duration of Study in the UK
0 years, 1 months, 14 days
Research summary
Concordance between digitized .rts images and digitized .ndpi images refers to an agreement in the diagnosis made when comparing these two (2) image file types in the Omnyx Dynamyx software.
The results of this study are intended to support the proposed use for the Hamamatsu image ingest of the .ndpi file type into the Omnyx Dynamyx software as follows: The Omnyx IDP System is intended for in vitro diagnostic use as an aid to pathology professionals for creating, managing, storing, annotating, measuring, and viewing digital Whole Slide Images (WSI) from formalin-fixed, paraffin-embedded (FFPE) tissue sections.
This study serves as a validation study for the Omnyx Dynamyx software and Hamamatsu .ndpi image file format, evaluating agreement of diagnosis between whole slide images (WSI) of the Omnyx system (Omnyx scanned .rts images and Omnyx Dynamyx software) and the Omnyx Dynamyx software with the Hamamatsu .ndpi images. The primary goal of this study is to demonstrate concordance between the two systems to validate the Omnyx Dynamyx software with the non-Omnyx .ndpi image file type which will allow Inspirata to register the product for clinical use in the EU and in Canada.
In 2013, the Omnyx system underwent a CE validation study for clinical use in Canada and the EU. The overall concordance rate in this study, when examining only major discrepancies was 100%. There were 2 of 213 cases that demonstrated a minor discordance yielding an overall concordance of 99.1%. Generally, this study demonstrated that there were no errors in diagnosis as a result of the digital modality. Since that time, Hamamatsu similarly was approved for clinical use in Canada and the EU with the .ndpi file format.
This study compares the agreement of concordance between WSI from both the Omnyx .rts and Hamamatsu .ndpi image file formats when viewed in the Omnyx Dynamyx software.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
19/WM/0006
Date of REC Opinion
22 Jan 2019
REC opinion
Favourable Opinion