Cancer Genetics Introduces Novel CML Fish Assay.Business Editors & Health/Medical Writers ORLANDO, Fla.--(BW HealthWire)--Dec. 7, 2001 Dec. 7-11: Orange County Convention Center The Orange County Convention Center (OCCC) is the primary public convention center in Central Florida. The large complex is located on International Drive, a major tourist area in Orlando, Florida. , Orlando, Florida, Booth Number: 773; Poster: 622 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. ) today introduced a highly sensitive 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 (FISH) assay for simultaneously detecting translocations t(9;22)(q34;q11) and associated deletions in the der(9) and der(22) chromosomes involved in 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. ). This novel FISH assay is aimed at reliable detection of the translocation translocation /trans·lo·ca·tion/ (trans?lo-ka´shun) the attachment of a fragment of one chromosome to a nonhomologous chromosome. Abbreviated t. , associated deletions, and amplification of the BCR/ABL fusion in pre-and post-treatment patient populations. The assay design eliminates false positive results in patient samples. Currently available probes detect the translocation with limited sensitivity and specificity and do not detect deletions, which are increasingly implicated in poor therapeutic outcome for CML patients. Dr. Nallasivam Palanisamy, Ph.D., Director of Genomic Research and Services reported (Poster 622): "Using our novel probe, we studied 70 unselected CML specimens for which t(9;22)(q34.1;q11.2) translocation status was confirmed by G-band karyotype analysis. 59 cases had t(9;22)(q34.1;q11.2), 8 had complex (variant) translocations, 2 cases had additional Ph (Philadelphia chromosome) chromosomes, and 1 cell line (K562) had a high level amplification of the BCR/ABL fusion region. 16 cases (23%) were found to have deletions on the rearranged chromosomes, 14 of which had deletions on der(9), and 2 of which had deletions on der(22), the Ph chromosome." Deletions on Ph chromosome are particularly important because the BCR/ABL fusion gene residing on this chromosome is implicated in CML development. Recent studies have shown that a sub set of CML cases had large deletions adjacent to the translocation breakpoints on the der(9) chromosome. Patients with deletions had a shorter survival time and high relapse following bone marrow transplantation Bone Marrow Transplantation Definition The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets. . Such losses due to 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. Dr. Palanisamy continued, "Using our new probe, we identified deletions on the Ph chromosome. CGI's new BCR/ABL probe is highly specific and sensitive for detecting deletions on both rearranged chromosomes. Identifying these deletions in CML patients at diagnosis allows clinicians to select better treatment options." Significance and Technology Background A signal segregation approach was used to generate probes from regions outside the breakpoints in the BCR and ABL genes, resulting in a highly sensitive and specific assay format. This probe design addresses the technical limitations associated with available cytogenetic cytogenetic /cy·to·ge·net·ic/ (-je-net´ik) 1. pertaining to chromosomes. 2. pertaining to cytogenetics. cytogenetic pertaining to or originating from the origin and development of the cell. and molecular methods in diagnostic and follow up assays for patient monitoring. Significant advantages of our assay format include: 1) both derivative chromosomes are detected by separate fusion signals, 2) overall assay sensitivity is increased due to the complete absence of false positive cells, 3) assay accuracy is increased because probes are derived from regions outside of all known breakpoints, and 4) there is no reduction in actual signal intensity, since probes do not overlap any of the breakpoints. The Company has filed patent applications covering this technology. Company Background CGI is a private company dedicated to understanding the genetic causes of cancer and developing products and services to improve patient management. Probes include: t(11;14)(q13;q32) and t(8;14)(q24;q32), which are recurrent chromosomal rearrangements in Mantle cell and Burkitt's lymphoma, respectively, and t(9;22)(q34;q11), the cause of chronic myeloid leukemia (CML). CGI's FISH probes are the most sensitive and accurate method for monitoring disease status for a number of B-cell lymphomas. Reliable, validated FISH probes for detecting translocations prevalent in lymphomas and leukemia's are not currently available. The Company also operates a 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 approved Cytogenetics cytogenetics /cy·to·ge·net·ics/ (-je-net´iks) the branch of genetics devoted to cellular constituents concerned in heredity, i.e. chromosomes. Services Laboratory and a Genomic Services Laboratory which both perform karyotyping Karyotyping A laboratory test used to study an individual's chromosome make-up. Chromosomes are separated from cells, stained, and arranged in order from largest to smallest so that their number and structure can be studied under a microscope. and chromosome analysis by G-banding, Spectral Karyotyping (SKY), FISH and comparative genomic hybridization hybridization /hy·brid·iza·tion/ (hi?brid-i-za´shun) 1. crossbreeding; the act or process of producing hybrids. 2. molecular hybridization 3. (CGH) for the clinical and research communities. The Company's services also include biopharmaceutical studies and clinical trial investigations. Test kits will be sold worldwide through distributors and its own sales force, used in its own Cytogenetics Services Laboratory reference lab, and made available selectively to commercial reference laboratories. |
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