Ki-67 Image Analysis and Digital Read Applications Cleared


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Ventana Medical Systems, Inc, received 510(k) clearance from the FDA for the Ventana Companion Algorithm Ki-67 (30-9) image analysis application used with the Ventana iScan Coreo Au scanner running Virtuoso software. Ventana is currently the only company offering an FDA-cleared Ki-67 image analysis algorithm for determining Ki-67 expression levels in breast cancer patients.

The Ki-67 protein is known to be an excellent marker for cellular proliferation. The Ki-67 (30-9) application may assist pathologists in achieving objective and consistent Ki-67 interpretation and can provide quantitative results for images with hundreds or thousands of cells.

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. ■



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