IVD Test Helps Determine Prognosis of Patients with CLL

The test detects genetic abnormalities in lymphocytes.

The Vysis CLL fluorescence in-situ hybridization (FISH) probe test is the latest addition to Abbott Molecular's (Abbott Park, IL, USA) growing list of US FISH in vitro diagnostics products. It 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 chronic lymphocytic leukemia (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.

FISH (fluorescence in-situ hybridization) technology can identify whether too many, or too few, copies of a particular gene are present in the body's cells or whether certain genes have rearrangements that play an active role in disease progression. Cancer diagnostics is one of its fastest growing applications.

Abbott's genetic FISH panel for leukemia patient prognosis has received 510k clearance from the US Food and Drug Administration (FDA; Silver Spring, MD, USA).

The most common form of leukemia in the United States and Europe, CLL is most commonly found in Caucasian men 60 years and older. In the United States, more than 15,000 patients are diagnosed with CLL each year, many of whom are discovered during routine medical exams.

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