FDA Sanctions Abbott's Genetic FISH Panel for Leukemia Prognosis
Test detects genetic abnormalities to aid in the prediction of chronic lymphocytic leukemia patient survival.
Abbott received 510k clearance for an in vitro diagnostic test to aid in determining the prognosis of patients with chronic lymphocytic leukemia (CLL). The Vysis CLL FISH Probe Kit is reportedly the first FDA-cleared CLL prognostic test.
It 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.
Several published studies and the National Comprehensive Cancer Network (NCCN) guidelines suggest that chromosomal abnormalities associated with CLL are valuable prognostic tools, Abbott points out. "Genetic aberrations are found in 80 percent of CLL cases,” according to Stafford O'Kelly, head of Abbott's molecular diagnostics business.
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 versus 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 the latest addition to Abbott Molecular's list of FISH in vitro diagnostics products in the U.S. Earlier this year the firm submitted a PMA to the FDA for its Vysis ALK Break Apart FISH Probe test designed to identify ALK-positive non-small-cell lung cancer patients for targeted therapy.
Abbott's PathVysion test, the first FDA approved FISH-based companion diagnostic, detects amplification of the Her2 gene and acts as an aid in identifying breast cancer patients for Herceptin® therapy. The UroVysion test also utilizes FISH technology to quantitatively assess chromosomal changes in the cell's nucleus, which may aid in the diagnosis as well as in the surveillance and monitoring of bladder cancer.