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(R) auto-amniocyte application for marketing in the United States.
fastFISH(R) auto-amniocyte, an application in the Company's fastFISH(R)
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(R) auto-amniocyte product is designed to run on the
Ikoniscope(R) robotic digital microscopy platform.
"We are pleased to introduce fastFISH(R) 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(R) 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(R) for the prenatal detection of
genetic disorders, both of which are designed to run on the company's
proprietary Ikoniscope(R) robotic digital microscopy platform. To date, the
company has obtained two FDA clearances for its fastFISH(R) 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 ikonisys.
Ikonisys, Inc
ikonisys