FOR IMMEDIATE RELEASE
FDA Clears BioView Duet™ System for Automated FISH Scanning of UroVysion™ Bladder Cancer Recurrence Test
Rehovot, Israel – August 22, 2005 – BioView Ltd, 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, 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.
The Duet™ 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 and Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21).
This new application for the DUETTM System will assist caregivers to monitor patients for recurrence of bladder cancer using the Vysis UroVysionTM Bladder Cancer Recurrence Kit. The UroVysion kit is from Vysis Inc., Downer’s Grove, IL.
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™ System on urine cells. In particular, we are pleased to have received clearance for the Duet to aid in the monitoring of specific chromosomal aberrations (3, 7, 17 and 9p21 locus) in patients with transitional cell carcinoma of the bladder. Based on the incidence and prevalence of the disease the potential market opportunity for these tests can reach approximately 1.5 million tests each year. By automating the scanning of the tests, which leads to cost efficiencies and improved quality control in the laboratory, we believe that these tests will become more widespread and will represent an important market opportunity. Coupled with the prior clearance of the Duet™ for hematopoietic cells and amniotic cells this clearance will enable us to broaden our market penetration 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. A privately owned company, BioView currently has strategic collaborations underway with international scientific leaders and institutions. For more information about the BioView technology, and press related issues, please contact alan@bioview.co.il or visit our website at www.bioview.co.il
