Interpretive software IVDs

Intended purpose

The Ibex platform is a software only device intended for supporting the pathologist in interpreting whole slide images (WSIs) of digitized glass slides originating from H&E stained histological glass slides. The application is designed to assist in normal pathology laboratory workflow as a first read, as a means to support the pathologist in the review of the slides, aiding in viewing and managing WSIs of stained histology specimens, identifying suspected findings and providing characterization, such as tissue classification and slide and/or case-level categorization of cancer likelihood and grade. The application results are not intended to be used as a standalone basis for a pathology report or diagnosis, nor are they intended to rule out cancer or otherwise preclude pathological assessment of WSIs. The Ibex platform includes solutions for prostate, breast, and gastric tissues, each with offerings for the following Indications for Use: Ibex Prostate is indicated for hematoxylin and eosin (H&E) stained adult prostate core needle biopsy (PCNB) specimens. The application provides tissue classification and slide-level categorization of cancer associated with prostate biopsies likelihood and grade. Ibex Breast is indicated for hematoxylin and eosin (H&E) stained adult women breast biopsy or excision specimens. The application provides tissue classification and case-level categorization of cancer associated with breast biopsies or excision specimens likelihood and grade. Ibex Gastric is indicated for hematoxylin and eosin (H&E) and hematoxylin-eosin-saffron (HES) stained adult gastric biopsy specimens. The application provides tissue classification and case-level categorization of cancer likelihood and grade, and key suspicious findings associated with gastric biopsies.