FDA approves Progesterone Receptor 1E2 Image Analysis System (Ventana Medical Systems) for Breast Cancer

The FDA has given 510(k) approval for the Ventana Companion Algorithm Progesterone Receptor (PR) (1E2) image analysis application used with the Ventana iScan Coreo Au scanner running VIRTUOSO software, from Ventana Medical Systems, for use in diagnosing Breast Cancer. The PR (1E2) image analysis algorithm assists pathologists in the detection and semi-quantitative measurement of PR expression in formalin-fixed, paraffin-embedded normal and neoplastic breast tissue. This application aids the pathologist in achieving consistency and objectivity in PR interpretation for Breast Cancer patients. When the PR (1E2) algorithm is used in conjunction with the Ventana Confirm anti-PR (1E2) Rabbit Monoclonal Primary Antibody, it may be used as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered but is not the sole basis for treatment. The FDA clearance includes all of the components of the Ventana laboratory workflow solution including the company's BenchMark slide stainer, exclusive PR clone 1E2, detection systems, slide scanner, and image management software.