FDA Clears Genetic FISH Panel for Leukemia Patient Prognosis


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FDAlogoAbbott announced it has received 510k clearance from the FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with chronic lymphocytic leukemia (CLL). Abbott’s Vysis CLL FISH Probe Kit is the first FDA-cleared CLL test to aid in prognosis. The test detects genetic abnormalities in lymphocytes. In CLL, abnormal lymphocytes are produced and can accumulate in the circulatory system, restricting normal cell function and weakening the immune system.

CLL progresses more slowly than other types of leukemia and most patients diagnosed with CLL have early-stage disease. Up to 50% are at risk for accelerated progression while others live for many years and often do not require therapy. Several published studies and the National Comprehensive Cancer Network (NCCN) guidelines suggest that chromosomal abnormalities associated with CLL are valuable prognostic tools.

The Vysis CLL FISH Probe Kit includes a panel of five individual FISH probes intended to detect deletion of the LSI TP53, LSI ATM and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell CLL. The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group vs the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology, and other clinical information. The Vysis CLL FISH Probe Kit is not intended for use in selection of therapy or in monitoring of residual disease. ■



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