FISH Assay for Acute Myeloid Leukemia

Period of Performance: 08/01/2001 - 07/31/2002


Phase 1 SBIR

Recipient Firm

Cancer Genetics, Inc.
Rutherford, NJ 07070
Principal Investigator


DESCRIPTION (Applicant's abstract): The goal of this research is to develop two fluorescence in situ hybridization (FISH) assays for detecting the t(8;21)(q22;q22) and inv(16)(p13q22) and related t(16;16)(p13;q22) translocations found in two different subsets of acute myeloid leukemia (AML), M2 and M4Eo, respectively. These cancers are traditionally treated by chemotherapy; however, many patients relapse and become refractory to treatment. Diagnosis and post treatment follow-up are currently performed by karyotype, Southern blotting or PCR. These methods, however, have limitations in specificity and/or sensitivity. A precise, reliable and simple method for detecting cancer cells, especially in post-treatment specimens, is needed. FISH is an improvement over current methods used for detecting translocations; however, no clinically tested probes are available for detecting AML. This SBIR proposal aims to develop novel, sensitive and specific FISH assays that will unambiguously detect translocation carrying nuclei in diagnostic and follow up patient samples. PROPOSED COMMERCIAL APPLICATION: The proposed research will provide highly specific and sensitive FISH assays for detecting chromosomal translocations present in Acute Myeloid Leukemia (AML) for use in cancer cytogenetic reference laboratories.