Aperio Technologies has received clearance from the FDA to market the IHC HER2 Breast Tissue Tunable Image Analysis application, available through its patented digital pathology platform.
The application is intended for use as an aid to the pathologist and accessory to the Dako HerceptTest, to aid in the detection and semi-quantitative measurement of HER2/new (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue.
Additionally, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN (Trastuzumab) treatment is being considered.
Dirk Soenksen, CEO of Aperio, said: “FDA clearance of Aperio’s tunable image analysis algorithm is an important milestone in breast cancer pathology because it allows labs to adjust the algorithm to adapt their own staining process to yield better results. With this clearance, Aperio continues its quest to improve the standardization of IHC and help advance personalized medicine. The next big step in IHC standardization will be to adjust the algorithm to variations in the staining process that occur from batch to batch.”