Ikonisys Gets FDA Clearance to Market Ikoniscope(TM) fastFISH(TM) Amnio Test System to the US Market
Posted on: Tuesday, 21 February 2006, 09:01 CST
NEW HAVEN, Conn., Feb. 21 /PRNewswire/ -- Ikonisys, Inc. announced today that the United States Food and Drug Administration (FDA) cleared for marketing in the United States its automated cell-locating device, the Ikoniscope(TM) fastFISH(TM) amnio Test System.
The Ikoniscope(TM) fastFISH(TM) amnio Test System is an automated scanning microscope coupled with image analysis, acquisition and display functions. It is intended for in vitro diagnosis as an aide to the technologist or pathologist in the detection, classification and enumeration of cells of interest based on particular characteristics such as intensity, size, shape or fluorescence. The Ikoniscope(TM) fastFISH(TM) amnio Test System is intended to detect amniotic cells stained by FISH using commercially available direct- labeled DNA probes or chromosomes X, Y, 13, 18 and 21.
"This is a major milestone for Ikonisys. It will give us the opportunity to market our first product, fastFISH(TM) amnio, to the largest market in the world. We are confident that our fastFISH(TM) amnio Test System along with the applications that will follow both in prenatal and oncology markets will have a major impact to our laboratory customers and the health of patients," said Dr. Petros Tsipouras, Chairman and CEO of Ikonisys.
Ikonisys is a privately held medical technology company that is developing products for diagnosing diseases early using chromosome FISH dot counting and rare-cell identification and analysis. Based on its proprietary technology, Ikonisys aims to expand a novel field of medical diagnostic analysis, namely cell-based diagnostics. Additional information about Ikonisys can be found at http://www.ikonisys.com/.
Contact: Petros Tsipouras, MD Ikonisys, Inc. (203) 776-0791
This release was issued through eReleases(TM). For more information, visit http://www.ereleases.com/.
Ikonisys, Inc.
CONTACT: Petros Tsipouras, MD, Ikonisys, Inc., +1-203-776-0791
Web site: http://www.ikonisys.com/
Source: PRNewswire
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