The Ventana System for Primary Diagnosis by Ventana Medical Systems Inc, a member of the Roche Group, has been CE marked in the European Union for routine pathology, including primary diagnosis with human tissue specimens (the system has not been approved or cleared for use in the United States).
The system, consisting of Ventana Virtuoso software coupled with either the Ventana iScan Coreo or the Ventana iScan HT slide scanner, provides automated digital slide creation, case management, and computer viewing of human tissue specimens. The new CE mark for application of the system in routine pathology, including primary diagnosis, takes digital pathology a step forward by expanding diagnostic options for a lab’s most common test—review of samples stained using hematoxylin and eosin (H&E)—while improving workflow, physician collaboration, and the standard of patient care.
“As more anatomic pathology laboratories routinely digitize 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,” says Steve Burnell, PhD, vice president and lifecycle leader for digital pathology and workflow at Ventana. “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.”
Adoption of digital pathology is accelerating as healthcare organizations face regional imbalances of pathology expertise. Digital pathology solutions offered by Ventana continue to improve patient care by enabling pathologists worldwide to gain access to physician networks offering subspecialty pathology expertise.
The iScan Coreo slide scanner is a brightfield 160-slide capacity scanner that provides a versatile system including four objective lenses as well as live-mode viewing. The iScan HT slide scanner is a high-throughput brightfield slide scanner with a 360-slide capacity, combining high reliability and high throughput at both 20x and 40x magnifications. Slides digitized on either scanner may be viewed and diagnosed in the Virtuoso Web-based software solution for viewing, managing, and sharing digital cases and glass slides.
In addition to the Ventana System for Primary Diagnosis, Ventana recently announced FDA clearance for its Estrogen Receptor (ER) image analysis and digital-read application for breast cancer, making it the only company offering an FDA-cleared testing package of five key breast cancer biomarkers with their corresponding image analysis algorithms and digital-read applications.
When the Ventana ER (SP1) algorithm is used in conjunction with the Confirm anti-ER (SP1) rabbit monoclonal primary antibody test, it may be used as an aid in the assessment of ER status in breast cancer patients for whom endocrine treatment is being considered but is not the sole basis for treatment.
Along with the companion algorithm ER (SP1) image analysis software, Ventana’s full breast panel includes HER2 (4B5), PR (1E2), Ki-67 (30-9) and p53 (DO-7) image analysis algorithms along with their accompanying immunohistochemical (IHC) assays.
All of the IHC breast markers in the Ventana portfolio have both image analysis and digital-read application FDA 510(k) clearance and CE marking under IVDD. The Pathway HER2 (4B5) assay is FDA-approved; the Confirm PR (1E2) and Confirm ER (SP1) assays are FDA-cleared; the Ki-67 (30-9) and p53 (DO-7) assays are FDA Class I exempt in vitro diagnostics.
For more information, visit Ventana Medical Systems Inc.