FDA Clears Abbott’s Genetic FISH Panel for Leukemia Patient Prognosis

Abbott announced today it has received 510k clearance from the U.S. Food and Drug Administration for a new in vitro diagnostic test to aid in determining the prognosis of patients with chronic lymphocytic leukemia (CLL), a cancer of the lymphocytes.

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. Lymphocytes, a type of white blood cell, help the body fight infection. In CLL, abnormal lymphocytes are produced and can accumulate in the circulatory system restricting normal cell function and weakening the immune system.

CLL is the most common form of leukemia in the U.S. and Europe and 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. CLL progresses more slowly than other types of leukemia and most patients diagnosed with CLL have early-stage disease. Up to 50 percent are at risk for accelerated progression while others live for many years and often do not require therapy.

“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 percent 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.”

Technical Information on the CLL FISH Assay

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.

About FISH

FISH (fluorescence in-situ hybridization) technology has a variety of uses. It 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 the fastest growing applications.

The Vysis CLL FISH Probe Kit is the latest addition to Abbott Molecular’s growing list of U.S. FISH in vitro diagnostics products. Earlier this year, Abbott submitted a pre-market approval application 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 HER-2 gene and acts as an aid in identifying patients for Herceptin® (trastuzumab) therapy for breast cancer. The Abbott 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.