[tri-wings] Re: FYI - CLINICAL TRIAL FOR EARLY, NON-INVASIVE TESTING OF DOWN SYNDROME
- From: "sharon gorvett" <sharog@xxxxxxxxxxxx>
- To: <tri-wings@xxxxxxxxxxxxx>
- Date: Wed, 13 Feb 2008 16:35:12 -0000
Very informative but how exactly will the circulating fetal cells be
obtained - is it by way of a 'smear' or 'pap' type test???
----- Original Message -----
From: "Karen Schuler" <trisomy@xxxxxxxxxxx>
To: "Tri-Med" <tri-med@xxxxxxxxxxxxx>; "Tri-Wings" <tri-wings@xxxxxxxxxxxxx>
Sent: Wednesday, February 13, 2008 1:25 AM
Subject: [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
>
>
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