Healthcare Industry News: Cytogen
News Release - December 4, 2006
Abbott Introduces CE-Marked DNA Tests in Europe for the Detection of Chromosomal Abnormalities Associated With LeukemiaHighly Sensitive FISH Technology Assists in the Accurate Detection of Chromosome Aberrations, an Important Predictor of Clinical Outcomes for Patients With Leukemia
DELKENHEIM, Germany, Dec. 4 (HSMN NewsFeed) -- Abbott Molecular today announced that it has introduced six CE-marked DNA tests in Europe for use by diagnostic laboratories in identifying chromosomal abnormalities associated with certain forms of leukemia, a cancer of the white blood cells originating in the bone marrow.
The tests are based on Abbott's proprietary fluorescence in situ hybridization technology (FISH) and employ DNA probes used to detect genetic abnormalities, such as extra or rearranged chromosomes, common in patients with acute lymphocytic leukemia (ALL), chronic myeloid leukemia (CML) and chronic lymphocytic leukemia (CLL). DNA probes are molecules stained with fluorescent dyes that recognize and bind to specific target molecules in patient samples. The fluorescent probes can be viewed under a special microscope, enabling the detection of chromosome gains, deletions or translocations.
The FISH tests are intended to supplement conventional Cytogenetics (the analysis of chromosomes) and in some cases provide additional information not detected by other test methods. Conventional Cytogenetics, for example, may indicate if large chromosome changes have occurred, whereas the FISH method targets specific, more cryptic chromosome defects known to be associated with cancers. Both methods are needed to tell treating physicians whether a particular cancer is present or has recurred and to determine the patient's prognosis.
"Combining traditional Cytogenetics with FISH testing provides doctors with the accurate information they need to make better decisions regarding treatment options and quality of life," said Prof. Christine Harrison, director, Leukaemia Research Fund Cytogenetics Group, Southampton General Hospital, UK
"Certain genetic aberrations can be important indicators of whether a patient has a particularly aggressive form of leukemia or whether they will respond to certain therapies," said Timothy Stenzel, M.D., Ph.D., medical director, Abbott Molecular. "Abbott's FISH technology helps physicians diagnose different leukemias that may look similar but have different genetic abnormalities and therefore may require different treatment."
The following six probes have received CE mark certification, allowing them to be commercially marketed in the European Union. They include the VysisŪ LSIŪ p53/LSI ATM and LSI D13S319/LSI 13q34/CEP 12 Multi-Color Probe Sets; Vysis LSI BCR/ABL Dual Color, Dual Fusion Translocation Probe Set (20 assays and 50 assays); Vysis LSI BCR/ABL ES Dual Color Translocation Probe Set; Vysis LSI BCR/ABL Dual Color, Single Fusion Translocation Probe Set; Vysis LSI MLL Dual Color, Break Apart Rearrangement Probe; and Vysis LSI 21 SpectrumOrange(TM) Probe. The six probes are already available in the United States.
These products represent the first in a series of CE-marked DNA probes that Abbott Molecular expects to launch in Europe in the coming months. Future probes will be offered for a variety of applications in cancer and genetic testing.
About Abbott Molecular
Abbott Molecular is a leader in the development and commercialization of FISH probes, offering a broad menu of tests for use in cancer diagnostics and genetic testing. The technology allows highly sensitive, direct detection of chromosomal abnormalities. It also permits the quantitative assessment of morphological changes in cells, enabling clinicians to investigate DNA in its native, chromosomal form within the cell nucleus. As correlations between genetic anomalies and disease are established, Abbott Molecular applies its technologies to develop clinical diagnostic products intended to provide information critical to the evaluation and management of cancer, prenatal disorders and other genetic diseases.
Leukemia is a malignancy of blood-forming tissues -- bone marrow, lymph nodes and the spleen. According to the World Health Organization, the global incidence of leukemia is about 8 to 9 per 100,000 people each year. Approximately 250,000 new cases occur annually worldwide. The disease appears as uncontrolled multiplication of abnormal white blood cells. Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in the U.S. and Europe, with an incidence of close to 3 cases per 100,000 people, and occurs particularly in the elderly.
Abbott (NYSE: ABT ) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
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