To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: CEP 12 SpectrumOrange DNA Probe Cleared by FDA URL: http://www.pslgroup.com/dg/197AE.htm Doctor's Guide January 27, 1997
DOWNERS GROVE, Ill., Jan. 27, 1997 -- Vysis, Inc. today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the company's CEP(R) 12 SpectrumOrange(TM) DNA Probe Kit, an in vitro diagnostic (IVD), for use as an adjunct to standard cytogenetic analysis to identify and enumerate chromosome 12 in interphase nuclei of cells obtained from peripheral blood lymphocytes in patients with B-cell chronic lymphocytic leukemia (CLL). "FDA clearance of Vysis' CEP 12 DNA Probe is another significant milestone as we continue to expand our portfolio of genomic assessment products to the clinical market," said John L. Bishop, president and CEO of Vysis, Inc. "Vysis looks forward to introducing a panel of probe kits for routine clinical use in managing leukemia. "An additional IVD product is under FDA review for assessing and managing bone-marrow transplant therapy in patients with leukemia. As well, we have begun clinical trials for a product that will provide information key to predict therapeutic outcome in breast cancer patients," added Bishop. The CEP 12 SpectrumOrange Probe Kit contains a "chromosome enumeration probe" (CEP) and associated reagents that Vysis has developed for routine clinical use to determine the presence of a chromosomal abnormality known as trisomy 12, which is a common chromosomal alteration in patients with CLL. Trisomy 12 occurs when three copies of chromosome 12 exist within a cell. "Studies suggest that the presence of trisomy 12 directly correlates with the stage of disease and overall survival in patients with CLL," said Susan Escudier, M.D., a clinical assistant professor, hematologist and oncologist at Baylor School of Medicine in Houston. "Trisomy 12 provides prognostic utility in that physicians may be able to identify earlier which patients have a worse prognosis, and thus choose the best treatment to achieve better long term results." Chronic Lymphocytic Leukemia Leukemia is a malignancy of blood-forming tissues -- bone marrow, lymph nodes and the spleen. Striking nearly 28,000 patients each year in the United States, the disease appears as uncontrolled multiplication of abnormal white blood cells. Studies show that trisomy 12 is the most common chromosomal abnormality in patients with a specific form of the disease, chronic lymphocytic leukemia (CLL). CLL is characterized by the presence in the blood of an increased number of mature lymphocytes. CLL is the most common form of leukemia in the Western world, with an incidence of close to 3 cases per 100,000 people, and occurs particularly in the elderly. CLL patients have a widely variable clinical course and many do not require therapy at the time of diagnosis. However, the morbidity and mortality of this disease should not be underestimated. While overall survival rates for leukemia have more than doubled in the last 30 years from 14 percent in 1960 to 40 percent in 1990, every 10 minutes another child or adult dies from the disease or related illness, according to the Leukemia Society of America. The CEP(R) 12 SpectrumOrange(TM) DNA Probe Assisting physicians to make more specific diagnostic and treatment decisions in managing the care of their patients, CEP 12* is the second IVD test utilizing Fluorescence In Situ Hybridization (FISH) technology available for routine clinical use. In December 1996, Vysis received FDA clearance to market its CEP(R) 8 SpectrumOrange(TM) DNA Probe Kit -- the first IVD test utilizing FISH -- for use as an adjunct to standard cytogenetic analysis to identify and enumerate chromosome 8 in interphase and metaphase spreads from the bone marrow of patients with myeloid disorders. Providing information useful in assisting the management of the patient's disease, the CEP 12 SpectrumOrange DNA Probe is used once confirmation of CLL is established and as an adjunct to standard cytogenetics. "FISH is much more sensitive than standard cytogenetics in detecting trisomy 12," said Robert B. Jenkins, M.D., Ph.D., co-director of the Cytogenetics Laboratory at the Mayo Clinic in Rochester, Minn., one of several sites where CEP 12 was evaluated. "A higher proportion of specimens having trisomy 12 will be detected using FISH as compared to standard cytogenetics." In clinical trials assessing the CEP 12 Probe's ability to identify trisomy 12 in comparison to conventional cytogenetics, the test showed a relative sensitivity of virtually 100% (39/39) and a relative specificity of about 91% (118/129), when data analysis was performed only among those samples with sufficient metaphases (those cells undergoing division) for standard cytogenetic analysis. In fact, FISH interphase analysis detected trisomy 12 in about 10% more cases than did cytogenetic analysis. The ability to analyze interphase chromosome spreads is of particular importance because of the low incidence of good quality metaphase spreads in many CLL patients. Patented FISH Technology The CEP 12 SpectrumOrange DNA Probe uses Vysis' patented FISH technology. FISH allows highly sensitive, direct detection of chromosomal abnormalities. It also permits the quantitative assessment of morphologically intact cells, thus enabling clinicians to investigate DNA in its native, chromosomal form within the cell nucleus. FISH further provides the unique ability to simultaneously assess multiple chromosomal and gene abnormalities in a single cell. After hybridization occurs between a DNA probe and its genetic target, a compact fluorescent signal can be observed with a fluorescence microscope and further analyzed with computer imaging equipment. The CEP 12 Probe highlights the chromosome's centromere (the pinched area at the center of a chromosome) with a bright orange signal, allowing the cytogeneticist to easily enumerate extra copies of chromosome 12. CEP 12 test results are available in less than three hours, which is faster than standard cytogenetic analysis, which can take several days. Vysis' core technologies include its patented direct-label FISH, Comparative Genomic Hybridization (CGH), and sequence-specific technology to identify genetic abnormalities. These technologies 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 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 driving the development of disease management with molecular techniques through the innovation and commercialization of genomic assessment products. In addition to its DNA FISH probes available for routine clinical use, Vysis currently markets an integrated line of advanced genetic imaging workstations, and more than 180 nucleic acid probes and reagents For Research Use Only. * CEP(R), WCP(R) and LSI(TM) direct-label, fluorescence probes are covered by U.S. Patent No. 5,491,224. LSI, WCP and other CEP probes are For Research Use Only and are not for use in diagnostic procedures. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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