The US Food and Drug Administration (FDA) has granted 510(k) approval to Ventana Medical Systems' Companion Algorithm p53 (DO-7) image analysis application.
The p53 image analysis application utilizes the company’s iScan Coreo Au scanner and Virtuoso software which facilitates pathologists to detect and semi-quantitatively measure p53 (DO-7) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue.
The company said when the p53 (DO-7) algorithm is used in conjunction with the Confirm anti-p53 (DO-7) primary antibody, it may be used to detect p53 expression in breast cancer patients.
Ventana digital pathology and workflow VP 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."
Ventana also received FDA approval for the digital read application that allows pathologists to use iScan Coreo Au scanner with Virtuoso software to interpret p53 (DO-7) stained slides as images on a computer monitor.