The FDA has granted Ventana Medical Systems, a member of the Roche Group, 510(k) clearance for its Ventana Companion Algorithm Ki-67 (30-9) image analysis application used with the Ventana iScan Coreo Au scanner running Virtuoso software.

The 510(k) clearance covers all components of the Ventana workflow solution used together, including the company's BenchMark slide stainer, Ki-67 (30-9) clone, detection systems, slide scanner and image management software.

The decision makes Ventana the only company offering an FDA cleared Ki-67 image analysis algorithm for determining Ki-67 expression levels in breast cancer patients.

Ventana also received FDA clearance for the digital read application that allows the pathologist to interpret Ki-67 (30-9) stained slides as images on a computer monitor with the Ventana iScan Coreo Au scanner and Virtuoso software.