[tri-wings] FYI - CLINICAL TRIAL FOR EARLY, NON-INVASIVE TESTING OF DOWN SYNDROME

****I am forwarding this article or URL for your information (FYI) as I
believe it may be of interest and is from a reliable source. As always,
check the information with your own doctor or health care professional
before starting or changing any treatments.****
http://www.ikonisys.com/new/?q=node/99

IKONISYS BEGINS CLINICAL TRIAL FOR EARLY, NON-INVASIVE TESTING OF DOWN SYNDROME 
 Novel, Diagnostic Solution to be Evaluated at King?s College Hospital in 
London  for Detection of Trisomy 21 in First Trimester of Pregnancy Using 
Circulating Fetal Cells      




Dallas, Texas, February 1, 2008 ? Ikonisys, a leading provider of non-invasive, 
cell-based diagnostic solutions, announced today at the Society for 
Maternal-Fetal Medicine (SMFM) Annual Meeting that it has begun a clinical 
trial evaluating its breakthrough test for early detection of chromosomal 
abnormality trisomy 21.  Early, non-invasive detection of genetic disorders, 
including Down syndrome, provides pregnant women with fast and accurate 
solutions that eliminate the need for repeat testing.  Led by renowned 
physician Professor Kypros Nicolaides of King?s College Hospital in London, the 
trial aims to validate the use of circulating fetal cells in early prenatal 
detection of Down syndrome within the first trimester of pregnancy. 

The trial is intended to establish accuracy and efficacy in the detection of 
trisomy 21 in circulating fetal cells. Ikonisys expects this solution to be the 
first in a suite of non-invasive cell-based fetal tests. 

 

?Although medical research and new technologies have enabled some genetic 
disorders to be detected throughout the first and second trimesters, there is 
still a false positive rate of three to five percent.  Unfortunately, this 
often translates to a need for several more invasive procedures,? said 
Professor Nicolaides, the director of the Harris Birthright Research Centre for 
Fetal Medicine at King?s College.  ?Through non-invasive testing of maternal 
fetal cells, we hope to replace a large portion of invasive testing, while 
simultaneously improving upon the detection rate and safety for detecting Down 
syndrome and other genetic disorders.? 

Ikonisys? innovative test is supported by its CellOptics® platform, a unique 
integration of intelligent imaging, microscopy, biology and informatics.  The 
company?s proprietary technology, the Ikoniscope®, is a robotic, optical 
microscope that offers labs high operational throughput, remote access and 
increased accuracy.   

  ?We are very excited to begin this clinical trial,? said Ikonisys CEO and 
Chairman Dr. Petros Tsipouras.  ?Prenatal procedures that detect genetic 
disorders can be expensive and labor intensive and are typically associated 
with an increased risk of miscarriage.  With this clinical trial, we seek to 
prove a novel test for early non-invasive, detection of Down syndrome that 
eliminates the need for repeat testing and offers women the reassurance, 
certainty and accuracy that they need to make better, more informed decisions.? 

About Ikonisys 


Ikonisys is changing the practice of diagnostic medicine through its unique 
CellOptics platform. Through an innovative combination of intelligent imaging, 
microscopy, biology and informatics, Ikonisys enables physicians and 
researchers to deliver accurate, fast and personalized results for early cancer 
diagnosis, genetic disorder screening and fertility testing.    

Ikonisys? solutions enable its customers to launch novel, new tests designed to 
achieve rare cell detection.  Ikonisys offers both large and regional reference 
labs, hospitals, research institutions and practice groups the ability to 
expand test volume capacity during an industry-wide shortage of trained 
technical personnel. 

In 2006, Ikonisys obtained FDA clearance for fastFISH amnio, an imaging 
application for the Ikoniscope® that provides automated identification of 
numerical aberrations of chromosomes associated with common birth defects.  
Additionally, in early 2007, the company received FDA clearance for oncoFISH 
bladder, an Ikoniscope® application that helps in the initial diagnosis of 
bladder cancer. 



About the Society for Maternal-Fetal Medicine (SMFM) 

The Society for Maternal-Fetal Medicine was established in 1977 and is the 
membership organization for obstetricians/gynecologists who have additional 
formal education and training in Maternal-Fetal medicine. There are currently 
about two thousand active members of the Society. The Society hosts an annual 
scientific meeting in which new ideas and research in the area of 
Maternal-Fetal Medicine are discussed and there are additional frequent 
Continuing Medical Education courses provided by our members throughout the 
world. The Society is also an advocate for improving public policy and 
expanding research funding and opportunities in the area maternal-fetal 
medicine. 

Media Contact: 

Jackie Hanley 

Racepoint Group            

781-487-4625 

jhanley@xxxxxxxxxxxxxxxxxx 

                  Building ___ooOOoo__ Rainbows
                       www.trisomyonline.org
                  Families Helping Families On-line

Other related posts: