Ikonisys Begins Clinical Trial For Early, Non-Invasive Testing Of Down Syndrome

Main Category: Pediatrics / Children's Health
Also Included In: Pregnancy / Obstetrics;  Clinical Trials / Drug Trials;  Genetics
Article Date: 06 Feb 2008 - 3:00 PST

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Ikonisys, a leading provider of non-invasive, cell-based diagnostic solutions, announced 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.

Society for Maternal-Fetal Medicine