Abbott has received 510k clearance from FDA for a new IVD 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.

"The recent clearance of the CLL test is another example of Abbott Molecular’s commitment to providing clinically validated products that support and improve patient care," said Stafford O’Kelly, head of Abbott’s molecular diagnostics business.

Several published studies and the National Comprehensive Cancer Network (NCCN) guidelines suggest that chromosomal abnormalities associated with CLL are valuable prognostic tools. O’Kelly went on to say, "Genetic aberrations are found in 80% of CLL cases. Abbott’s Vysis CLL FISH Probe test can aid in accurate disease prognosis by identifying patients with early-stage disease who could be at high risk for disease progression."

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 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. The Vysis CLL FISH Probe Kit is not intended for use in selection of therapy or in monitoring of residual disease.