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FDA clears marketing of disease management tests.(Food and Drug Administration)

Women's Health Weekly

| November 14, 2002 | COPYRIGHT 2002 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2002 NOV 14 - (NewsRx.com & NewsRx.net) -- ChromaVision Medical Systems, Inc., (CVSN), a provider of automated cell-imaging systems and manufacturer of the ACIS digital microscope system, announced that the U.S. Food and Drug Administration (FDA) cleared for marketing the use of its ACIS system to perform two tests used to help physicians determine an appropriate course of treatment for breast cancer patients.

The cleared ACIS applications detect, measure, and quantify the presence of estrogen receptors and progesterone receptors (commonly referred to as ER/PR) at the cellular level, allowing physicians a more precise and quantitative understanding of the specific traits of individual cancer tumors. In this clearance, the FDA indicated this ACIS application for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.

A large percentage of ChromaVision's customers have already conducted internal validation studies and perform ER/PR testing using ACIS. This specific clearance is intended to enable broadened marketing and promotional efforts and provide the company with the ability to make specific claims ...

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