Roche Group member Ventana Medical Systems has received the CE mark for its Ventana System for Primary Diagnosis in the European Union (EU).
The new CE mark extends the system's application to routine pathology, including primary diagnosis with human tissue specimens.
Ventana digital pathology and workflow vice-president and lifecycle leader Dr Steve Burnell said: "As more anatomic pathology laboratories routinely digitise patient slides, it's important that the most critical and commonly prepared stain, the H&E, can be reliably scanned and interpreted by a pathologist using a computer monitor for primary diagnostic purposes.
"This CE marking under the EU'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."
Featuring Ventana Virtuoso software integrated with either the Ventana iScan Coreo or the Ventana iScan HT slide scanner, the system has been designed to provide automated digital slide creation, case management and computer viewing of human tissue specimens.
According to Ventana, the system is yet to be approved or cleared by the FDA for use in the US.
The FDA recently cleared Ventana's Estrogen Receptor (ER) Image Analysis and Digital Read Application for breast cancer.
The clearance makes the company the first and only firm in the industry to offer an FDA-cleared five key breast biomarkers with their corresponding image analysis algorithms and digital read applications for cancer patients.
Image: The Ventana System for Primary Diagnosis. Photo: courtesy of Ventana Medical Systems.