FDA clears Aperio breast tissue image analysis app
Aperio Technologies has received clearance from the FDA to market its IHC HER2 breast tissue image analysis application.
According to the Vista, Calif.-based company, the IHC HER2 breast tissue image analysis application is intended to be used as an aid to the pathologist and accessory to the Dako HerceptTest to help in the detection and semi-quantitative measurement of HER2/new in formalin-fixed, paraffin-embedded normal and neoplastic tissue.
The application is indicated for use as an aid in the assessment of breast cancer patients for whom Herceptin treatment is being considered and can be tuned to accommodate a laboratory’s staining process.
According to the Vista, Calif.-based company, the IHC HER2 breast tissue image analysis application is intended to be used as an aid to the pathologist and accessory to the Dako HerceptTest to help in the detection and semi-quantitative measurement of HER2/new in formalin-fixed, paraffin-embedded normal and neoplastic tissue.
The application is indicated for use as an aid in the assessment of breast cancer patients for whom Herceptin treatment is being considered and can be tuned to accommodate a laboratory’s staining process.