FDA clears Aperio Technologies to market breast tissue image analysis application

Aperio Technologies, Inc., (Aperio), a global leader in digital pathology for the healthcare and life sciences industry, has received clearance from the U.S. Food and Drug Administration (FDA) to market the IHC HER2 Breast Tissue Image Analysis application, available through its patented digital pathology platform.

Immunohistochemistry is increasingly being used for the evaluation of therapeutic biomarkers. The IHC HER2 Breast Tissue Tunable Image Analysis 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. It is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. The application can be independently tuned to accommodate a laboratory’s unique staining process, providing better performance than out-of-the-box applications that use the same fixed settings across all laboratories.

“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,” said Dirk G. Soenksen, CEO of Aperio. “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.”

The IHC HER2 algorithm is Aperio’s first FDA-cleared tunable image analysis algorithm. Aperio’s digital IHC system comes with a suite of additional image analysis algorithms for research use only that can be tuned for different tissue types (e.g. colon, prostate), stains (e.g. ER, PR, Ki-67, P53, EGFR), and reagents (e.g. Dako, Ventana).

Aperio’s FDA clearance encompasses the company’s complete digital pathology system, including ScanScope^® scanners for creating digital slide images from microscope slides, the Spectrum^TM digital pathology information management system for managing, viewing, and analyzing digital slides, and the specific image analysis application that performs the automated scoring of IHC HER2 breast cancer digital slides.