The approval allows the system to be used in routine pathology, including primary diagnosis with human tissue specimens.
The system, including VENTANA Virtuoso software coupled with either the VENTANA iScan Coreo or the VENTANA iScan HT slide scanner, offers automated digital slide creation, case management and computer viewing of human tissue specimens.
Ventana noted that the new CE mark for their application in routine pathology including primary diagnosis takes digital pathology a big step forward by expanding diagnostic options for a lab’s most common test Hematoxylin and Eosin (H&E).
Ventana Medical Systems vice-president and digital pathology lifecycle leader Dr Steve Burnell said the most critical and commonly prepared stain H&E can be reliably scanned and interpreted by a pathologist using a computer monitor for primary diagnostic purposes.
"This CE marking under the European Union’s In Vitro Diagnostics Directive (IVDD) represents another significant step by Roche to assist pathologists in transitioning to a digital workflow and providing the highest standards of patient care," Burnell added.
The iScan Coreo slide scanner is a brightfield 160-slide capacity scanner, which provides a versatile system, including four objective lenses and live mode viewing.
The VENTANA iScan HT slide scanner is a high-throughput brightfield slide scanner with a 360-slide capacity that combines high reliability and high throughput at both 20X and 40X magnifications.
Recently, Ventana received FDA clearance for its Estrogen Receptor (ER) Image Analysis and Digital Read Application for breast cancer, in addition to the VENTANA System for Primary Diagnosis.
The US FDA has not approved or cleared the VENTANA System for primary diagnosis.
Image: VENTANA System for Primary Diagnosis. Photo: courtesy of Ventana Medical Systems, Inc.
