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Cancer Genetics Awarded Phase II SBIR to Develop Novel Lymphoma Probes.


Business Editors & Health/Medical Writers

BIOWIRE2K

CAMBRIDGE, Mass.--(BW HealthWire)--Sept. 28, 2001

Cancer Genetics, Inc. (CGI) today announced that it was recently awarded a Phase II Small Business Innovation Grant (SBIR) by the National Institutes of Health to develop a novel set of fluorescence in situ hybridization Fluorescence in situ hybridization (FISH)
A technique for diagnosing DiGeorge syndrome before birth by analyzing cells obtained by amniocentesis with DNA probes. FISH is about 95% accurate.
 (FISH) probes for detecting the t(14;18)(q32;q21)(BCL2/IGH) chromosomal translocation which results in non-Hodgkin's lymphoma (NHL NHL Non-Hodgkin's lymphoma, see there ). The enhanced specificity and sensitivity afforded by CGI's proprietary dual color, dual fusion assay permits simultaneous detection of both derivative (14) and (18) chromosomes.

The incidence of non-Hodgkin's lymphoma (NHL) has increased dramatically and it is now the fifth most common cancer in the US. Approximately 85% of B cell lymphomas are characterized by the presence of the BCL2/IGH chromosomal translocation. Diagnosis and post treatment follow up are currently performed by karyotype, Southern blotting, or PCR PCR polymerase chain reaction.

PCR
abbr.
polymerase chain reaction


Polymerase chain reaction (PCR) 
, which all have inherent limitations. Use of FISH assays address these limitations.

According to Dr. Nallasivam Palanisamy, Ph.D., Principal Investigator and Director of Genomic Research and Services, "Preliminary results show that our probes can be used to both diagnose new non-Hodgkin's lymphoma cases and monitor patients for minimal residual disease following chemo/monoclonal antibody therapy or 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.
".

"Compared to conventional probes that identify only one derivative chromosome with a single fusion signal, our dual color, dual fusion probes detect very small numbers of tumor cells present in a population of normal cells, and do not generate false positive signals", Dr. Palanisamy continued.

Background and Significance

New immunophenotypic markers as well as use of molecular methods such as PCR have revealed the highly heterogeneous nature of lymphoma. Accurate diagnosis and residual disease monitoring are particularly challenging. Cytological and histological methods were previously the diagnostic methods of choice. The t(14;18)(q32;q21) translocation results in the juxtaposition of the BCL2 gene on chromosome 18q21 with the immunoglobulin heavy chain (IGH) gene on chromosome 14q32, causing overexpression of BCL2, which maintains the neoplastic neoplastic /neo·plas·tic/ (ne?o-plas´tik)
1. pertaining to a neoplasm.

2. pertaining to neoplasia.


neoplastic

pertaining to neoplasia or a neoplasm.
 proliferation of B-cells.

Non-Hodgkin's lymphomas are treated by a variety of chemotherapeutic regimens, monoclonal antibodies, and autologous bone marrow transplantation autologous bone marrow transplantation Transplantation medicine The administration to an individual 'X' of his/her own BM, often to a leukemic Pt in relapse who, because a suitable HLA-matched donor is not available, would otherwise die of the disease. See Bone marrow. . Regular follow-up is performed to assess recurrence. The current clinical practice of karyotype analysis, requiring multiple probes and multiple PCR reactions is cumbersome and labor intensive.

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 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.
). 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 leukemias are not currently available.

The Company also operates a Cytogenetics Services Laboratory (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) 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.
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Publication:Business Wire
Date:Sep 28, 2001
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