Three New Cellular Imaging Tests Launched

Tests for thymidylate synthase (TS), epithelial cell adhesion molecule (Ep-CAM), and micrometastases detection in neuroblastoma have been introduced. The tests are designed to help doctors determine if new and aggressive therapies are appropriate for a patient and to guide the use of existing therapies.

Thymidylate synthase is essential for synthesis of DNA and is present in elevated amounts in some cancer patients. TS inhibitors show promise for treating colorectal and other cancers. Immunotherapeutic strategies targeting the Ep-CAM molecule have been used clinically and appear to have therapeutic potential for breast, ovarian, colon, and lung cancers. Detection of micrometastatic neuroblastoma cells is critical to proper disease staging and treatment, particularly since most victims are less than five years old.

The new tests are for the Automated Cellular Imaging System (ACIS) of ChromaVision Medical Systems, Inc. (San Juan Capistrano, CA, USA). The company says ACIS substantially improves the accuracy, sensitivity, and reproducibility of cell-based testing. ACIS combines color-based imaging technology with automated microscopy. The system was recently cleared by the U.S. Food and Drug Administration (FDA) for in vitro diagnostic use as an aid to pathologists in the detection and classification of specific rare cancer cells in bone marrow specimens.

The rapid advent of novel genetic and antibody therapeutics demands quantitative, specific, and standardized testing methods to correctly identify patients who will benefit from a particular drug or therapy, stated Douglas S. Harrington, M.D., chairman and CEO of ChromaVision.