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FDA Clears Leukemia Test

By Drug Discovery Trends Editor | August 23, 2011

NORTH CHICAGO, Ill. (AP) – Abbott Laboratories said the Food and Drug Administration cleared a genetic test that can help determine the prognosis of patients with chronic lymphocytic leukemia.

Abbott’s Vysis CLL FISH Probe Kit detects genetic abnormalities in lymphocytes, a type of white blood cell that helps fight off infections. In patients with chronic lymphocytic leukemia, abnormal lymphocytes are produced. Those abnormal cells can weaken the body’s immune system because they build up in the circulatory system and interfere with normal cell functions.

CLL is the most common type of leukemia in the U.S., as Abbott said around 15,000 cases diagnosed per year. The cancer typically progresses slowly and some patients do not require therapy. About half of all patients are at risk for faster disease progression, and the Vysis test can help identify those patients.

The FDA recently approved a related Vysis test that can help identify breast cancer patients who can benefit from the drug Herceptin, which is marketed by Roche. Abbott is also seeking approval for a test that identifies a genetic mutation in non-small cell lung cancer. Those patients can benefit from Pfizer Inc.’s lung cancer drug candidate crizotinib.
 
Date: August 22, 2011
Source: Associated Press


Filed Under: Drug Discovery

 

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