FDA approves Abbott’s genetic test for leukemia

Earlier on Monday, Abbott Laboratories announced that a genetic test intended to diagnose chronic lymphocytic leukemia (CLL) patients has been approved by the United States Food and Drug Administration.

The Vysis CLL FISH Probe Kit by Abbott has been designed to detect genetic lymphocytic abnormalities. Chronic lymphocytic leukemia patients produce abnormal lymphocytes that deteriorate the body’s immune system because they obstruct normal cell functions by accumulating in the circulatory system.

According to Abbott, nearly 15,000 cases of CLL are diagnosed in the US annually. Typically, the cancer advances gradually, and therapy is not required in some patients. Rapid disease progression is observed in nearly 50% patients, who can be identified with the Vysis test.

A test similar to Vysis was recently approved by the FDA. Breast cancer patients who can benefit from the drug Herceptin (marketed by Roche) can be identified by this test. Approval is also being sought by Abbott for a genetic test that detects non-small cell lung cancer mutations in patients who benefit from crizotinib, a lung cancer drug by Pfizer Inc.
In morning trading, Abbott shares jumped 68 cents to $49.76.

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