Healthcare Industry News:  Herceptin 

Diagnostics Oncology FDA

 News Release - January 25, 2007

FDA Clears BioView Duet(TM) System for Automated FISH Scanning of Breast Cancer Tissue Specimens

REHOVOT, Israel, January 25 (HSMN NewsFeed) -- BioView Ltd, (TASE: BIOV) from Rehovot, Israel, announced today that the United States Food and Drug Administration (FDA) cleared for marketing in the United States its automated scanning microscope and image analysis system, the DuetTM System, to detect and quantify chromosome 17 and the HER-2/neu gene via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens, probed by the Vysis PathVysion(TM) Her-2 DNA Probe Kit. The Duet(TM) is to be used as an adjunctive automated enumeration tool, in conjunction with manual visualization, to assist in determining HER-2/neu gene to chromosome 17 signal ratio.

The Duet(TM) System is intended for in-vitro diagnostic use as an aiding tool to the pathologist in the detection, classification and counting of cells of interest based on color, intensity, size, pattern, and shape. The DuetTM had previously received FDA clearance for Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension, amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21) and for cells in urine specimens, stained by FISH using the Vysis UroVysionTM Bladder Cancer Recurrence Kit for chromosomes 3, 7, 17 and 9p21 locus, from subjects with transitional cell carcinoma of the bladder.

This new application for the DUETTM System will assist caregivers in the analysis of the FISH signals in tissue specimens of breast cancer patients. This test is an important factor in the evaluation and selection of certain breast cancer patients for Genentech's Herceptin (Trastuzumab) therapy. Herceptin is the first humanized antibody approved for the treatment of Her-2 positive metastatic breast cancer. Herceptin targets and blocks the overexpression of Her-2 protein. Research indicates that women with Her-2 positive metastatic breast cancer have a more aggressive disease, greater likelihood of recurrence, poorer prognosis and approximately half the life expectancy of women with Her-2 negative breast cancer.

The Duet HER-2/neu FISH application uses the PathVysion HER-2/neu DNA Probe Kit from Vysis, Inc., a wholly owned subsidiary of Abbott Laboratories.

Bioview's automated scanning microscope and image analysis system will help laboratories provide highly reliable test results to physicians and patients quickly and cost-effectively.

Opher Shapira, President and CEO of BioView Ltd, said, "We are pleased to have received FDA clearance for the new extended use of the Duet(TM) System on human breast cancer tissue specimens. Coupled with the prior clearance of the Duet(TM) for hematopoietic cells, amniotic cells and urine cells this clearance will enable us to broaden our market penetration into the pathology marketplace and firmly establish BioView as the leader in FISH automation systems worldwide."

"BioView continues to develop additional applications for cancer screening, diagnostics and minimal residual disease. Our commitment is to offer the most advanced image analysis systems to assist the pathologist and cytogeneticist in classifying and counting cells of interest utilizing our advanced algorithms for both brightfield and fluorescent scanning. We believe that BioView offers the only automated system that enables laboratories to perform a wide range of genetic tests based on fluorescent in situ hybridization (FISH) technology, combined with morphology or immunohistochemical staining in order to provide important genetic data to the caregiver."

About BioView Ltd.

Established in 2000, and led by an expert team of biologists, software engineers and physicists, BioView develops, manufactures and supplies cell imaging equipment, biological kits and software to medical institutes and universities. BioView is a publicly traded company on the Israeli Stock exchange, and currently has strategic collaborations underway with international scientific leaders and institutions. For more information about the BioView technology, and press related issues, please contact info@bioview.co.il or visit our website at www.bioview.co.il.


Source: BioView

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