US FDA clears ACIS system to perform tests to determine breast-cancer treatment

OCTOBER 2--ChromaVision Medical Systems Inc. (San Juan Capistrano, CA; www.chromavision.com), provider of automated cell-imaging systems and manufacturer of the Automated Cellular Imaging System (ACIS) digital microscope system, announced that the US Food and Drug Administration (FDA) has cleared for marketing the use of its ACIS system to perform two tests used to determine treatment for breast-cancer patients. The cleared ACIS applications detect, measure, and quantify the presence of estrogen receptors and progesterone receptors at the cellular level, allowing physicians a more precise and quantitative understanding of the specific traits of individual cancer tumors.

The ChromaVision ACIS system can be applied to multiple existing laboratory diagnostic and prognostic tests and is designed to greatly enhance the precision and accuracy of the physician's characterization of disease at the cellular level utilizing color. The ACIS combines proprietary, color-based imaging technology with automated, digital microscopy to increase detection sensitivity more than 300 percent over existing manual testing methods.