Abbott Laboratories Inc. said Monday that regulators approved a test that helps determine the prognosis of patients with acute myeloid leukemia.
The Vysis EGR1 FISH Probe Kit can help physicians determine which patients can be treated with chemotherapy, the first option for AML, and who has more severe disease and may require a stem cell transplant. The test detects a deletion in part of a chromosome that is associated with more severe disease.
Abbott said about 12,000 cases of AML are diagnosed per year in the U.S.
The Food and Drug Administration has approved three of Abbott’s FISH tests in recent months. Earlier this year the agency gave marketing clearance for a test that can help identify breast cancer patients who can benefit from the drug Herceptin, and another test that helps determine the prognosis of patients with chronic lymphocytic leukemia.
Shares of Abbott lost 37 cents to $53.49 in afternoon trading. The company said Wednesday that it plans to split into two companies, separating its branded drug unit from the division that sells nutritional formula, generic drugs and heart stents.
