|
FOR IMMEDIATE RELEASE For
more information contact: FDA Clears Applied Spectral Imaging's BandViewTM Karyotyping System
Migdal Ha'Emek, Israel, September 25, 2001 - Applied Spectral Imaging (ASI) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its BandView™ karyotyping system. BandView™ has been cleared for in vitro diagnostic use as an aid to cytogeneticists in diagnosing birth defects, genetic diseases, cancer and the effect of cancer treatments. H. Laurence Shaw, MD, CEO of ASI, is confident that this FDA clearance will increase the demand for ASI's cytogenetic imaging analysis systems. "Five years ago, ASI revolutionized the field of cytogenetic research with the SKY™ technique, which uncovers hidden abnormalities in chromosomes. Now, with BandView™, we are offering clinical laboratories a robust diagnostic tool that can quickly give accurate results. BandView™ rounds out and completes our cytogenetic products so that we can both sell in the clinical market as well as expand our sales in the research arena." BandView™, which is compatible with all current banding techniques, simplifies the karyotyping process by combining high-quality image processing with a complete working environment for the cytogeneticist. The system incorporates a high resolution CCD-camera, acquisition and analysis software, as well as ASI's Case Data Manager™, an integrated image database which includes flexible report generation features. The BandView™ system can be expanded to include ASI's spectral karyotyping (SKY™) system as well as FISH. ASI is a privately held imaging company based in Israel, with wholly owned subsidiaries in Carlsbad, California and Mannheim, Germany. ASI has developed and commercialized products in cytogenetics. In addition, it has brought to market SpectraView™, a general analytical imaging system which may be used in a wide range of applications and industries. This press release contains forward-looking statements that are subject to risks and uncertainties. Factors that could cause actual results to differ materially from these forward-looking statements include, but are not limited to, general business conditions in the industry, market acceptance of new products, changes in demand for products, the timing and amount or cancellation of orders and other risks. |