The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ventana Medical Systems' companion algorithm progesterone receptor (PR) (1E2) image analysis application for use with the company's iScan Coreo Au scanner running Virtuoso software.
The PR (1E2) image analysis algorithm facilitates pathologists to detect and semi-quantitatively measure PR expression in formalin-fixed, paraffin-embedded normal and neoplastic breast tissue.
Ventana Confirm anti-PR (1E2) rabbit monoclonal primary antibody when used along with the PR (1E2) algorithm, may be used as an aid to assess breast cancer patients for whom endocrine treatment is being considered but is not the sole basis for treatment.
The company said the FDA clearance includes all of the components of the its laboratory workflow solution including slide stainer, PR clone 1E2, detection systems, slide scanner, and image management software.
Ventana digital pathology and workflow vice president Steve Burnell said the addition of PR (1E2) algorithm to the company’s complete digital pathology workflow solution will assist pathologists in generating consistent and objective results.