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Cancer Genetics, Inc. Launches Revolutionary Weapon for the War on Cancer.


Business Editors/Health/Medical Writers

SAN DIEGO--(BUSINESS WIRE)--Dec. 5, 2003

At the American Society of Hematology meeting today in San Diego, CA, Cancer Genetics, Inc. (CGI CGI
 in full Common Gateway Interface.

Specification by which a Web server passes data between itself and an application program. Typically, a Web user will make a request of the Web server, which in turn passes the request to a CGI application program.
) launched a new, highly sensitive DNA DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
 FISH assay to help diagnose and monitor therapy of chronic myeloid leukemia (CML 1. CML - A query language.

["Towards a Knowledge Description Language", A. Borgida et al, in On Knowledge Base Management Systems, J. Mylopoulos et al eds, Springer 1986].
2. CML - Concurrent ML.
) and a subset of acute lymphoblastic leukemia acute lymphoblastic leukemia
n. Abbr. ALL
Lymphoblastic leukemia occurring mainly in older adults, characterized by rapid onset and progression of symptoms. Also called acute lymphocytic leukemia.
 (ALL). This assay is the first "repeat-free" BCR/ABL four color fluorescent in situ hybridization in situ hybridization A method for localizing a sequence of DNA, mRNA, or protein in a cell or tissue; the use of a DNA or RNA probe to detect a cDNA sequence in chromosome spreads or in interphase nuclei or an RNA sequence of cloned bacterial or cultured  (F-FISH) probe and it is CGI's first product to be introduced into the United States.

This F-FISH platform is used to simultaneously detect the t(9;22)(q34.1;q11.2) translocations, associated deletions, variants, and amplifications which occur in CML. The assay design improves sensitivity and specificity, eliminating false positive and false negative results in patient samples. The design of earlier generation probes limited sensitivity and specificity and may not detect deletions and atypical signal patterns arising from complex rearrangements.

Nallasivam Palanisamy, Ph.D., inventor of the assay reports: "Our validation studies of the F-FISH assay showed deletions in 20% of known standard translocation translocation /trans·lo·ca·tion/ (trans?lo-ka´shun) the attachment of a fragment of one chromosome to a nonhomologous chromosome. Abbreviated t.  cases." Deletions on the der(9) chromosome are particularly important as they are shown to be associated with resistance to treatment and possibly contribute to poor clinical outcomes (Sinclair et al., 2000). Submicroscopic submicroscopic /sub·mi·cro·scop·ic/ (-mi?kro-skop´ik) too small to be visible with the light microscope.

sub·mi·cro·scop·ic
adj.
 deletions are not detectable by conventional G-band analysis and this information obtained through the F-FISH assay may give physicians a window of opportunity to adjust therapy and treatment.

Significance and Technology Background

The F-FISH probe was developed by using CGI's proprietary Signal Exchange Approach methodology, wherein probes are derived from the regions flanking genes which contain the breakpoints. The Company has filed patent applications covering its proprietary signal segregation approach, signal exchange approach, and repeat removal technology. Cancer Genetics, Inc. probes are labeled with the patented Universal Linkage System (ULS ULS Universal Licensing System
ULS Universidad de La Serena (Chile)
ULS Ultimate Limit State (British steelwork standard)
ULS Ultra Low Sulfur (vehicle fuel) 
(TM)) from KREATECH Biotechnology BV, Amsterdam, The Netherlands. For more information on the advantages of F-FISH please visit our website at www.cancergenetics.com.

Company Background

Cancer Genetics Inc., is a private company founded by Dr. R.S.K Chaganti, a world renowned leader in cancer genetics. CGI is dedicated to understanding the genetic causes of cancer and is developing products and services to improve patient therapy, diagnostics and management. CGI's FISH probes are the most sensitive and accurate method for monitoring disease status for Lymphomas, Leukemias, Multiple Myeloma, and Cervical Cancer. CGI continues making strides through the introduction of innovative technologies for cancer research.

Cancer Genetics products maybe used in clinical diagnostic laboratory systems after the laboratory has validated their complete system as required by CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a  '88 regulations in the US, or equivalent in other countries.
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Publication:Business Wire
Date:Dec 5, 2003
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