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