FOR IMMEDIATE RELEASE
FDA Clears BioView’s Automated Image Analysis System- The Duet™ System for USA Marketing
Rehovot, Israel – September 3, 2003 – 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 in-vitro diagnosis use, as an aiding tool to the pathologist in the detection, classification and counting of cells of interest based on particular color, intensity, size pattern and shape.
This particular application of the DuetTM is intended to detect hematopoietic cells positively stained by Giemza stain, Immunohistochemistry or ISH (bright field and fluorescent) prepared from cell suspension. The device has been cleared for use without limitation to specific diseases.
The BioView DUETTM System assists caregivers to diagnose and monitor patients with hematological pathologies. Bioview’s advanced technology rapidly links morphological analysis with FISH (Fluorescent in-situ hybridization) technology which allows the pathologist to analyze the same cell by both methods, for example, morphology and FISH staining. According to BioView, the utilization of its system generates increased information that is not provided by any other commercial technology while providing fast, accurate and highly sensitive results.
The Duet™ System has been used in several leading clinical and hospital laboratories for research use, prior to the FDA clearance.
Opher Shapira, President and CEO of BioView Ltd, said, "We are pleased to have received FDA clearance for the use of the Duet™ System on hematopoietic cells. This clearance is intended to enable broadened marketing and promotional efforts and provide the company with the ability in the future to make specific claims as to the diagnostic value of the Duet™ system.”
“We intend to use this clearance as a platform for future applications of other types of cells as well as for specific diseases. 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
