While overall survival rates for leukemia have more than doubled in the last 30 years from 14 percent in 1960 to 40 percent in 1990, every 10 minutes another child or adult dies from the disease or related illness, according to the Leukemia Society of America. Providing information useful in assisting the management of the patient's disease, the CEP 12 SpectrumOrange DNA Probe is used once confirmation of CLL is established and as an adjunct to standard cytogenetics. A higher proportion of specimens having trisomy 12 will be detected using FISH as compared to standard cytogenetics. The ability to analyze interphase chromosome spreads is of particular importance because of the low incidence of good quality metaphase spreads in many CLL patients. The CEP 12 SpectrumOrange DNA Probe uses Vysis ' patented FISH technology.
FISH allows highly sensitive, direct detection of chromosomal abnormalities.
It also permits the quantitative assessment of morphologically intact cells, thus enabling clinicians to investigate DNA in its native, chromosomal form within the cell nucleus. FISH further provides the unique ability to simultaneously assess multiple chromosomal and gene abnormalities in a single cell. After hybridization occurs between a DNA probe and its genetic target, a compact fluorescent signal can be observed with a fluorescence microscope and further analyzed with computer imaging equipment. CEP 12 test results are available in less than three hours, which is faster than standard cytogenetic analysis, which can take several days. These technologies are providing new molecular approaches to assess the genome at all levels, including the ability to determine the presence, absence, number and structure of chromosomes, individual genes and their base sequences.