China Medical Wins Approval for Leukemia FISH Probe

Nov.10.09 | About: China Medical (CMEDQ)

China Medical Technologies (NSDQ: CMED) received SFDA approval for its Leukemia BCR/ABL fusion gene detection FISH Probe. The probe uses DNA probes to detect Philadelphia translocation, a chromosomal abnormality associated with three forms of leukemia. Detecting Philadelphia translocation is a critical diagnosis and prognosis tool for selecting the different treatment protocols appropriate for chronic myelogenous leukemia, acute lymphoblastic leukemia and acute myelogenous leukemia.

At this point, China Medical Technology has received SFDA approvals for all the major FISH probes it acquired as part of the FISH business in March 2007 (HER-2 FISH Probe, Prenatal FISH Probe, Cervical Cancer FISH Probe, Bladder Cancer FISH Probe and Leukemia BCR/ABL FISH Probe).

The FISH probes developed by the company after its acquisition of the FISH technology (the EGFR molecular diagnostic kits, Prostate Cancer FISH Probe, Lymphoma FISH Probe, Sarcoma FISH Probe and FISH probes related to other forms of leukemia) are either in the clinical trial stage or under SFDA review.

Philadelphia translocation is the result of a reciprocal translocation between chromosomes 9 and 22. The translocation results in the presence of a fusion gene that is created by juxtaposition of a part of the breakpoint cluster region (BCR) gene from chromosome 22 to the Abelson (ABL) gene on chromosome 9.

"We believe we have become a leading developer and manufacturer of FISH probes in China with the most comprehensive FISH probes for clinical screening, diagnosis and prognosis," commented Mr. Xiaodong Wu, Chairman and CEO of China Medical Technology in a statement.

China Medical’s FISH technology has been a great success for the company. It produced $14.4 million in revenues during Q1 of 2009 (ended June 30, 2009). The company paid $136.8 million to acquire the FISH technology in 2007, with an additional $40 million in incentives if milestones were met.

Disclosure: none.