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Women's Health Weekly

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Breast Cancer



U.S. FDA clears use of automated scanning system for PathVysion DNA



January 27th, 2005

The U.S. Food and Drug Administration (FDA) has cleared for marketing Abbott's Vysis AutoVysion System for use with the Vysis PathVysion HER-2 DNA Probe Kit as an aid in determining HER-2 gene status in women who have been diagnosed with breast cancer.

AutoVysion, developed in collaboration with MetaSystems, GmbH, is designed to be used with Abbott's proprietary fluorescence in situ hybridization (FISH) technology and utilizes an automated scanning microscope and computer-assisted imaging system to aid in the detection and counting of FISH signals from breast cancer tissue sections.

It is intended for laboratory use as an accessory to PathVysion, a...


Source: Women's Health Weekly (2005-01-27)

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