An equivalency study conducted with Histolix’s fluorescence imitating brightfield imaging (FIBI) technique showed no major discordance in comparison to traditional formalin-fixed and paraffin-embedded (FFPE) pathology standards.
The FIBI technology could reduce analysis time from the current eight hours or more to under 10 minutes. It could also eliminate most of the process and time constraints by creating a digital image without the slide at the point-of-care, according to Histolix.
To demonstrate efficacy, Histolix conducted an equivalency validation study, in parallel with U.S. Food and Drug Administration (FDA) study standards for digital pathology. The results showed FDA-level diagnostic concordance through four third-party readers and 800 reads of 22 tissue types.
In the study, the categories of concordance or minor discordance were scored as "no major discordance." The overall agreement rate compared to the reference diagnosis across 800 reads was 97.9%. This consisted of 400 FIBI reads at 97% in comparison to 400 hematoxylin and eosin stain reads versus reference at 98.8%, according to the company.