Healthcare Industry News:  bladder cancer 

Diagnostics FDA

 News Release - September 28, 2006

Ikonisys Receives FDA Clearance for Prenatal Testing Application

fastFISH auto-amniocyte launched in the U.S.

NEW HAVEN, Conn., Sept. 28 (HSMN NewsFeed) -- Ikonisys Inc., a leading developer of cell-based diagnostic products, today announced that the United States Food and Drug Administration (FDA) has cleared the Company's fastFISH® auto-amniocyte application for marketing in the United States.

fastFISH® auto-amniocyte, an application in the Company's fastFISH® suite of products, allows for the automated identification and enumeration of chromosomes 13, 18, 21, X, and Y in amniotic fluid cells via FISH (Fluorescence In Situ Hybridization). Numerical aberrations of these chromosomes are associated with common birth defects including Down syndrome. The fastFISH® auto-amniocyte product is designed to run on the Ikoniscope® robotic digital microscopy platform.

"We are pleased to introduce fastFISH® auto-amniocyte to our customers," said Petros Tsipouras, M.D., Chairman and Chief Executive Officer of Ikonisys. Dr. Tsipouras continued, "We believe that physicians and consumers will appreciate fastFISH® auto-amniocyte's rapid and reliable functionality. Further, this application provides laboratories with an economical solution to the industry-wide shortage of trained technical personnel."

About Ikonisys

Ikonisys develops, commercializes and markets a robotic digital microscopy platform. The Company's products will address the areas of cancer diagnosis and management, prenatal detection of genetic disorders, and fertility. Ikonisys is focused on becoming the standard in robotic digital microscopy, providing laboratories with cost-effective, "walk-away" functionality. The Company is developing two product lines: oncoFISH(TM) for cancer diagnostics and fastFISH® for the prenatal detection of genetic disorders, both of which are designed to run on the company's proprietary Ikoniscope® robotic digital microscopy platform. To date, the company has obtained two FDA clearances for its fastFISH® auto-amniocyte product related to the automated analysis of chromosome FISH signals in amniocytes. The pipeline includes several products in cancer diagnostics including bladder cancer. Additional information about Ikonisys and the Company's products can be found at http://www.ikonisys.com.


Source: Ikonisys

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