Ventana Medical Systems, a member of the Roche Group, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Companion Algorithm p53 (DO-7) image analysis application.
Using the company’s iScan Coreo Au scanner and Virtuoso software, the p53 image analysis application allows pathologists to detect and semi-quantitatively measure p53 (DO-7) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue.
In conjugation with the Confirm anti-p53 (DO-7) primary antibody, the p53 (DO-7) algorithm can be used as a tool to determine p53 expression in breast cancer patients, the company said.
The FDA clearance also covers all of the components of the Ventana laboratory workflow solution when used as a system, including the BenchMark XT slide stainer, p53 clone DO-7, iView and ultraView DAB detection systems, Ventana iScan Coreo Au slide scanner and Virtuoso image management software.
Ventana Medical Systems president Mara Aspinall said: "We provide the most clinically validated, FDA-cleared digital pathology algorithms in the market today. When you combine this with our broad portfolio of instruments and assays, and our expertise in laboratory knowledge management and workflow, it is clear that Ventana is positioned to deliver the most comprehensive digital pathology solutions available globally."
Ventana’s digital pathology and workflow vice president Steve Burnell said: "Our increasing Companion Algorithm portfolio of FDA-cleared products is evidence both of our unique capabilities in this field, as well as our commitment to empower our customers to deliver the highest standards of patient care through the most robust digital pathology solutions available."
Image: The p53 image analysis application from Ventana has been approved by the FDA. Photo courtesy of: FDA.