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Abbott Fish Probe Kit receives FDA nod

Abbott has received the US Food and Drug Administration (FDA) 510k approval for its Vysis CLL Fish Probe Kit to determine the prognosis of patients with chronic lymphocytic leukemia (CLL).

The Vysis CLL Fish Probe Kit includes a panel of five individual Fish probes which are used to find out 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 is used to dichotomize CLL and helps in determining disease prognosis in combination with additional biomarkers, morphology and other clinical information.

Abbott molecular diagnostics business head Stafford Kelly said Abbott’s Vysis CLL Fish Probe test can aid in disease prognosis by identifying patients with early-stage disease who could be at high risk for disease progression.