SFDA Approves Leukemia BCR/ABL Fusion Gene Detection FISH Probe
China Medical Technologies, Inc. has announced that the Company has received approval for its Leukemia BCR/ABL fusion gene detection FISH Probe (the “Leukemia BCR/ABL FISH Probe”) from the State Food and Drug Administration of China (the “SFDA”). The Leukemia BCR/ABL FISH Probe is a molecular diagnostic test kit that uses DNA probes for accurate detection of Philadelphia translocation, which is a specific chromosomal abnormality associated with chronic myelogenous leukemia.

The FDA has decided to postpone the approval for Genesense (oblimersen sodium) due to the lack of adequate data available for the drug. The drug is used in relapsed or refractory chronic lymphocytic leukemia. The Center for Drug Evaluation and Research (CDER) and the FDA agreed that the drug achieved the primary endpoint in the pivotal trial, drug maker