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Ventana HER2 image analysis, digital read application wins FDA approval

Ventana Medical Systems, a member of the Roche Group, has received the US Food and Drug Administration (FDA) 510(k) approval for its HER2 (4B5) image analysis and digital read applications to determine HER2 (4B5) expression in breast cancer patients.

The approval covers all components of the workflow including the 4B5 clone, slide stainer, detection systems, software and scanner.

The image analysis application aids pathologist in the detection and semi-quantitative measurement of HER2 (4B5) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue.

The digital read application facilitates pathologist to see HER2 (4B5) stained slides as images on a computer monitor with Virtuoso software and iScan Coreo Au scanner