NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing Abbott's Vysis CLL FISH Probe Kit for determining the prognosis of patients with chronic lymphocytic leukemia.
The test detects genetic abnormalities in lymphocytes, and according to Abbott is the first FDA-cleared CLL test to aid in prognosis. It includes five 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.
Abbott noted that the test is not intended for use in selecting therapy or monitoring of residual disease.
More than 15,000 patients are diagnosed with CLL in the US each year.