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| |  FDA Clears First In Vitro Diagnostic DNA FISH Probe ORLANDO, Fla., Dec. 9, 1996 -- Vysis, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the company's CEP(R) 8 SpectrumOrange(TM) DNA Probe Kit, an in vitro diagnostic (IVD) to identify and enumerate abnormal chromosomes of leukemia patients. Assisting physicians in making more specific diagnostic and treatment decisions in managing the care of their patients, CEP 8* is the first IVD test utilizing Fluorescence In Situ Hybridization (FISH) technology available for clinical use. The announcement was made here at the 38th annual conference of the American Society of Hematology. "The availability of this new diagnostic marks the advent of disease management with molecular techniques for a wide variety of genetically based disorders," said Robert B. Jenkins, M.D., Ph.D., associate director of the Cytogenetics Laboratory at the Mayo Clinic in Rochester, Minn., where the test is being used. "Clinicians now have a powerful tool to perform chromosome-specific analysis, gaining information at the molecular level to assess the stage of this persistent blood disease and to determine the most appropriate treatment." The CEP 8 SpectrumOrange Probe Kit contains a "chromosome enumeration probe" (CEP) and associated reagents Vysis has developed for routine clinical use that allow the diagnostic professional to determine if chromosome 8 is present in abnormal numbers. The CEP 8 Probe is used as an adjunct to standard cytogenetics to determine the presence of a chromosomal abnormality known as trisomy 8. Trisomy 8 occurs when three copies of chromosome 8 exist within a cell, and is a key prognostic indicator for patients with leukemia and other myeloid disorders. "The CEP 8 Probe is a valuable adjunct test that gives clinicians more information than conventional cytogenetics may immediately provide, especially when results from conventional techniques are inconclusive," added Dr. Jenkins. The CEP 8 SpectrumOrange DNA probe uses Vysis' patented FISH technology. FISH allows highly sensitive, direct visual detection of chromosomal abnormalities and the quantification of abnormal cells using fluorescence-labeled probes -- segments of labeled DNA produced in the laboratory designed to bind, or "hybridize," with the target DNA of a chromosome under investigation. FISH enables the clinician to investigate DNA in its native, chromosomal form within the cell nucleus. It can detect four abnormal cells in one hundred. 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 8 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 8. CEP 8 test results are available in less than three hours, which is quicker than standard cytogenetic analysis. The CEP 8 SpectrumOrange DNA Probe is used once confirmation of a myeloid disorder or leukemia is established through standard cytogenetics. Used on patient samples of bone marrow, the test provides information useful in assisting the management of the patient's disease. In clinical trials assessing the CEP 8 Probe's ability to identify trisomy 8 in comparison to conventional cytogenetics, the test showed a relative sensitivity of 96 percent and relative specificity of 98 percent when performed on interphase cells (cells not undergoing division). When used with metaphase cells (those undergoing cell division), the CEP 8 Probe results demonstrated a relative sensitivity of 89 percent and a relative specificity of 91 percent. 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 8 indicates the presence of malignant tissue. Trisomy 8 frequently is seen in patients with chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), myeloproliferative disorder, myelodysplastic syndrome and other hematological disorders not otherwise specified. "Thirty years ago there was no effective treatment for leukemia -- individuals diagnosed with chronic disease typically survived only a few years, while those with acute disease died within months," explained Dr. Jenkins. "The CEP 8 DNA Probe may enable clinicians to clarify questionable cases and to assist in the prognosis and monitoring of the disease, thereby providing greater physician and patient confidence in treatment regimens." 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 most common type of leukemia in adults is AML with an estimated 6,800 new cases annually. CML strikes about 6,000 persons each year. "We are gratified to have achieved this key milestone, marking the industry's first FISH probe to move from the research lab to the clinic," said John L. Bishop, president of Vysis, Inc. "Vysis looks forward to providing the clinical community with other genomic assessment products to improve the management of disease with molecular techniques. "We currently have two additional products under review at the FDA for use in leukemia and other myeloid disorders. Vysis further expects to initiate clinical trials in January 1997 for a product for the assessment of breast cancer," he added. 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. 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 currently markets an integrated line of advanced genetic imaging workstations, and more than 180 nucleic acid probes and reagents For Research Use Only. Vysis' core technologies include its patented direct-label Fluorescence In Situ Hybridization (FISH) and Comparative Genomic Hybridization (CGH) to identify genetically altered regions in tissue, and sequence specific technologies for gene structure abnormalities. These technologies provide clinical researchers with powerful new molecular approaches to assess the genome at all levels, including the ability to determine the presence, absence, number and structure of chromosomes, and individual genes. Such additions and deletions are commonly present in cancer and other genetic diseases. * CEP(R), WCP(R) and LSI(TM) direct-label fluorescence probes are covered by U.S. Patent No. 5,491,224. LSI and WCP probes are for research use only and are not for use in diagnostic procedures.
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