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| |  First Rapid Test Registered in France For Prenatal Detection of Down Syndrome PARIS and DOWNERS GROVE, Ill. -- July 2, 1997 -- Vysis, Inc. has received registration from the Agence du Medicament (ADM) to market in France the company's TriGen(TM) Assay. Providing accurate and definitive results in less than 24 hours from uncultured amniocytes, TriGen is registered for use as a diagnostic test for the detection of trisomy 21 (abnormal presence of an extra copy of chromosome 21) associated with Down syndrome, and aneuploidy (the incorrect number of a chromosome) of chromosomes X and Y associated with Turner syndrome and Klinefelter syndrome, among others. Registration by the ADM allows Vysis to market TriGen in other European countries. The product is not available for sale in the United States. According to Moncef Benkhalifa, Ph.D., scientific director of cytogenetics at Laboratoire Marcel Merieux in Lyon, France, and the lead investigator of clinical trials for TriGen, using TriGen to obtain a rapid diagnosis of these syndromes in a fetus provides significant advantages in pregnancy management. "When an abnormality related to trisomy 21 is detected by fetal sonography in a late gestation pregnancy, a rapid diagnosis is critical," said Dr. Benkhalifa. "The anxiety imposed on parents as they wait for test results from conventional cytogenetic procedures causes unnecessary mental distress. TriGen, with its 24-hour results, addresses both of these issues." TriGen is a DNA probe panel comprised of LSI(R) 21 SpectrumOrange(TM) and CEP(R) X SpectrumGreen(TM)/CEP Y-alpha SpectrumOrange. TriGen is the first diagnostic test available in France and throughout Europe utilizing Fluorescence In Situ Hybridization (FISH) for clinical use.* FISH allows highly sensitive, direct visualization of chromosomes 21, X and Y, and enables the detection and quantification of chromosome copy number using fluorescent-labeled probes -- segments of labeled DNA produced in the laboratory to bind, or "hybridize," with target regions of these chromosomes. "TriGen's registration from the ADM marks the first prenatal diagnostic claim for a clinical product utilizing FISH technology," said John L. Bishop, president and chief executive officer of Vysis, Inc. "This acceptance of FISH as a clinical tool will assist obstetricians and gynecologists in managing their patients by providing rapid, definitive test results that enable timely decisions regarding patient treatment and care. "Because of its notable and demonstrated advantages, FISH technology is now clearly emerging from research utility to a highly desirable clinical diagnostic tool," added Bishop. TriGen's Clinical Performance In multinational clinical trials designed to assess TriGen's ability to identify trisomy 21 and aneuploidy of chromosomes X and Y, TriGen demonstrated 100 percent accuracy and 100 percent reliability when compared to traditional fetal karyotype analysis. Data are based on the analysis of amniotic fluid specimens obtained from 632 cases. Clinical trials were conducted at 18 sites, including Laboratoire Marcel Merieux in Lyon, France; le Laboratoire Hospitalier de Cytogenetique in Grenoble, France; Universitats Klinikum, Charite in Oberhausen, Germany; and Universidad Autonoma de Barcelona in Spain. "TriGen is a very innovative chromosomal testing device, with excellent accuracy and reproducibility. Data from clinical tests conducted at Laboratoire Marcel Merieux indicated that 100 percent of TriGen results were consistent with karyotyping results. In addition, TriGen could detect mosaics of sex chromosomes that were not diagnosed by karyotyping," added Dr. Benkhalifa. Down Syndrome and Prenatal Testing in France Down syndrome is a non-hereditary congenital disease that is caused by the presence of an extra copy of chromosome 21 (trisomy 21). Trisomy 21 in fetal cells (amniocytes) indicates the presence of Down syndrome in a fetus. An extra copy of chromosome 21 is found in up to 95 percent of all Down syndrome cases, which is the major cause of mental retardation in about one in 800 newborns. Studies indicate that trisomy 21 is frequently found in the fetus of pregnant women over 35 years of age. Klinefelter syndrome is a genetic abnormality that is caused by the presence of an extra X chromosome, and is typically identified as XXY. Klinefelter syndrome occurs in about one of every 600 male births. Turner syndrome is the result of a loss of one chromosome X. Typically identified as XO, Turner syndrome occurs in about one of every 2,500 female births. According to the European Journal of Human Genetics, more than 50,000 amniocentesis procedures are performed each year in France. The country's Ministry of Health recently passed a landmark regulation that permits all women with high-risk pregnancies to receive reimbursable prenatal screening, regardless of age. Prior to this initiative, only pregnant women with specific risk factors were allowed to receive reimbursable prenatal testing services. Benefits of FISH Technology There has been an increased demand for fetal karyotyping as a result of this initiative. Fetal karyotyping, which is the traditional method for detecting chromosomal abnormalities, is an expensive and time-consuming process that requires cell culturing and isolation of metaphase cells (cells that have divided). While results from fetal karyotyping may be available in 10 to 15 days, a diagnosis is frequently not available for up to three weeks. TriGen can provide results in 24 hours or less, is more cost effective and requires fewer technical resources to produce results. "For women at risk for trisomy 21, TriGen will allow us to dramatically improve the services offered to women in terms of information regarding their pregnancy," said Veronique Bellec, M.D., clinical director of cytogenetics at Laboratoire Marcel Merieux. FISH technology provides rapid, definitive results on uncultured cells, thus eliminating the technically burdensome requirements of cell culturing and metaphase isolation. FISH enables the clinician to investigate DNA in its native form within the cell nucleus. "The ADM's registration of TriGen for diagnostic use in prenatal testing -- in addition to recent clearances by the Food and Drug Administration in the United States for three of our FISH probes for use in hematological cancers -- exemplifies Vysis' emergence as the leader in genetic diagnostics," said Bishop. "Vysis will continue to provide clinical FISH assays to the medical community, which will allow more rapid, cost-effective methods for managing disease." Vysis' proprietary technologies and testing platforms are providing new molecular approaches to assess the genome at all levels, including the ability to determine the presence, absence, number and structure of chromosomes, individual genes and their base sequences. As correlations between genetic anomalies and diseases are established, the company's strategy is to apply its core technologies to rapidly develop clinical diagnostic products that will provide information critical to the evaluation and management of prenatal disorders, cancer and other genetic diseases. Vysis, Inc., of Downers Grove, Ill., is a genomic diagnostics company that develops and commercializes molecular-based clinical tests and genetic testing platforms for improved disease management. More information on: Vysis, Inc.
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