FDA clears Aperio's breast cancer image analysis product
This article was originally published in Clinica
The US FDA has granted 510(k) clearance for Aperio Technologies' IHC HER2 Breast Tissue Image Analysis software, to help assess breast cancer patients. Immunohistochemistry (IHC) is used to measure HER2 protein levels in tumour tissue samples, as HER2-positive breast cancer patients respond to HER2-targeting therapies like Roche's Herceptin (trastuzumab). Aperio's product uses computer algorithms to enhance or quantify the digital slide image to help the pathologist interpret their findings. It can be adjusted to a lab's unique staining process, leading to better results, the Vista, California company claimed.