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Lenetix Announces Commencement Of Screening Study To Detect Down Syndrome

Lenetix, Inc. announced that it has initiated an IRB approved screening study of an improved first and second trimester non-invasive fetal diagnostic test to detect Down syndrome. Lenetix PloidYX maternal blood test promises to be the most accurate and comprehensive test, developed for the detection of fetal aneuploidies and the presence of extra chromosomes, which cause Down syndrome (T-21) and other chromosomal abnormalities. 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. In the first and/or second trimester of pregnancy, risk assessment for Down syndrome is routinely offered to patients. 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. Lenetix PloidYX technology directly interrogates the fetal chromosomal status non-invasively, detecting not only Down syndrome (Trisomy 21), but also detects 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.