China Medical Technologies, Inc. (China Medical Technologies) has received State Food and Drug Administration (SFDA) approval from China for its Leukemia BCR/ABL fusion gene detection FISH Probe.
The company claims that 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 (CML), acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML). Philadelphia translocation is the result of a reciprocal translocation between chromosomes 9 and 22. The translocation results in the presence of a fusion gene which is created by juxtapositioning of a part of the breakpoint cluster region (BCR) gene from chromosome 22 to the Abelson (ABL) gene on chromosome 9. CML, ALL and AML are some of the most common types of leukemia, and detecting Philadelphia translocation is a critical diagnosis and prognosis guidance for selecting different treatment protocols for patients with CML, ALL and AML.
Mr. Xiaodong Wu, Chairman and Chief Executive Officer of the Company commented: “We believe our FISH probes will continue to drive a healthy growth for our company by generating sustainable and recurring revenue. We are also confident that our newly developed FISH probes will be approved by the SFDA in the future on a timely basis.”