FDA has granted market clearance for the companion algorithm ER (SP1) by Ventana Medical Systems, making Ventana the only company to offer a complete suite of image analysis algorithms and digital read applications for the 5 key immunohistochemistry (IHC) breast markers.
The presence or absence of estrogen receptors (ER) in cancer cells plays a critical role in breast cancer treatment. FDA’s clearance will enable clinical use of the algorithm to semi-quantify ER status, and will permit pathologists to read and score the biomarker on a computer monitor instead of a microscope, without necessarily using the image analysis algorithm.
The algorithm has been approved for use with the Ventana iScan Coreo scanner running Virtuoso software. Ventana’s full breast panel includes HER2 (4B5), PR (1E2), Ki-67 (30-9), and p53 (DO-7) image analysis algorithms along with their corresponding IHC assays.
For more information, visit Ventana.