The US Food and Drug Administration 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 FISH-based test designed to detect amplification of the HER-2 gene in breast cancer tissue specimens to assist in identifying which women are potential candidates for Herceptin (trastuzumab) monoclonal therapy. FISH provides the ability to see multiple chromosomal abnormalities simultaneously in a single cell and to visually assess these genetic abnormalities in patient specimens.

PathVysion is indicated for use as an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage II, node-positive breast cancer patients; as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin and 5-fluorouracil (CAF) chemotherapy; and as an aid in the assessment of patients for whom Herceptin treatment is being considered.

In October, Abbott announced an agreement with BioGenex Laboratories to distribute and market a new system that will automate the processing of FISH tests in a "walk-away" manner and provide a finished slide ready for the pathologist to read.

"We're making important investments to further automate our molecular diagnostics technology," said Edward L. Michael, president, Abbott Molecular Diagnostics, Abbott "The clearance of AutoVysion and our recent external collaborations demonstrate our commitment to delivering products that help our laboratory customers provide highly reliable test results to physicians and patients quickly and cost-effectively."