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Lenetix Launches Screening Study of New Down Syndrome Test
Date:2/5/2009

MINEOLA, N.Y., Feb. 5 /PRNewswire/ -- Lenetix, Inc. today announced the launch of an Institutional Review Board (IRB)-approved screening study of an improved first and second trimester non-invasive fetal diagnostic test to detect Down syndrome. The Lenetix PloidYX(TM) maternal blood test promises to be the most accurate and comprehensive test yet developed for the detection of fetal aneuploidies, the presence of extra chromosomes, which cause Down syndrome (T-21) and other chromosomal abnormalities.

Risk assessment for Down syndrome is routinely offered to patients in the first and/or second trimester of pregnancy. These evaluations rely on indirect ultrasound and biochemical exams, which are of imperfect accuracy. Patients deemed "at risk" by these tests are generally referred for genetic counseling and amniocentesis or CVS, invasive testing procedures which are known to cause miscarriages. The Lenetix PloidYX technology directly interrogates the fetal chromosomal status non-invasively, detecting not only Down syndrome (Trisomy 21), but other aneuploidies such as Trisomy 13, 18, and deviations in the numbers of the sex chromosomes. The superior accuracy of the Lenetix test promises fewer false positives and will therefore greatly reduce the number of unnecessary invasive tests -- and the fetal losses they can cause.

"We take deep pride in the technology we have developed because it has the potential to impact the lives of millions of women and their unborn children," said Lenetix president and CEO Leonard H. Kellner. "Patients and doctors are constantly required to weigh the importance of an invasive and possibly unneeded procedure against the possible harm it could cause, and we are confident that this current IRB assessment is the next step towards making that difficult decision unnecessary."

"Pregnant women and their physicians are clamoring for an improved, non- invasive prenatal test for Down syndrome because they fear the risks of amniocentesis," said Steve Brown, M.D., Lenetix Medical Director. "Our test offers the promise of a comprehensive assessment of fetal aneuploidy in the first trimester using a maternal blood sample. It's a higher-quality test that will protect the mother and fetus."

"I'm personally honored to be involved in this clinical trial, because I believe it will change Down syndrome testing forever," said Jonathan Herman, M.D., a practicing obstetrician on Long Island. "No longer will I have to use indirect tests, like proteins from the baby and mom, to figure out who is at high risk. In the near future I will be able to test the chromosomes directly, and that's very exciting."

About the Lenetix PloidYX Test

The Lenetix PloidYX Test makes use of methylation differences between the fetal and maternal DNA that is found in maternal blood in order to achieve selective amplification of the fetal component. Following amplification, a microarray analysis makes it possible to determine the relative copy number of all the chromosomes. An increase/decrease in the relative copy number of chromosomes is indicative of trisomy or monosomy respectively.

About Lenetix, Inc.

Founded in 2001, Mineola, New York-based Lenetix(R), Inc is a privately owned diagnostic laboratory providing innovative technologies focusing on diagnostic testing and risk assessment in oncology, prenatal diagnosis and assessment of genetic disease. The Lenetix scientific team has nearly 30 years experience in developing new tests used by healthcare providers and researchers worldwide. For more information, visit http://www.lenetix.com.


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SOURCE Lenetix, Inc.
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