BEIJING, Nov. 9 China Medical Technologies,Inc. (the "Company") (Nasdaq: CMED), a leading China-based medical devicecompany that develops, manufactures and markets advanced in-vitro diagnosticproducts, today announced that the Company has received approval for itsLeukemia BCR/ABL fusion gene detection FISH Probe (the "Leukemia BCR/ABL FISHProbe") from the State Food and Drug Administration of China (the "SFDA").
The Leukemia BCR/ABL FISH Probe is a molecular diagnostic test kit thatuses DNA probes for accurate detection of Philadelphia translocation, which isa specific chromosomal abnormality associated with chronic myelogenousleukemia ("CML"), acute lymphoblastic leukemia ("ALL") and acute myelogenousleukemia ("AML"). Philadelphia translocation is the result of a reciprocaltranslocation between chromosomes 9 and 22. The translocation results in thepresence of a fusion gene which is created by juxtapositioning of a part ofthe 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 commontypes of leukemia, and detecting Philadelphia translocation is a criticaldiagnosis and prognosis guidance for selecting different treatment protocolsfor patients with CML, ALL and AML.
As of today, the Company has received SFDA approvals for all the majorFISH probes that the Company acquired as part of the FISH business in March2007, which include HER-2 FISH Probe, Prenatal FISH Probe, Cervical CancerFISH Probe, Bladder Cancer FISH Probe and Leukemia BCR/ABL FISH Probe. TheFISH probes that the Company developed after its acquisition of the FISHbusiness in March 2007, such as the EGFR molecular diagnostic kits, ProstateCancer FISH Probe, Lymphoma FISH Probe, Sarcoma FISH Probe and FISH probesrelated to other forms of leukemia, are either in the clinical trial stage orunder SFDA review.
"We believe we have become a leading developer and manufacturer of FISHprobes in China with the most comprehensive FISH probes for clinical screening,diagnosis and prognosis," commented Mr. Xiaodong Wu, Chairman and ChiefExecutive Officer of the Company. "We believe our FISH probes will continue todrive a healthy growth for our company by generating sustainable and recurringrevenue. We are also confident that our newly developed FISH probes will beapproved by the SFDA in the future on a timely basis."
About China Medical Technologies, Inc.
China Medical Technologies is a leading China-based medical device companythat develops, manufactures and markets advanced in-vitro diagnostic (IVD)products using Enhanced Chemiluminescence (ECLIA) technology, Fluorescent insitu Hybridization (FISH) technology and Surface Plasmon Resonance (SPR)technology to detect and monitor various diseases and disorders. For moreinformation, please visit http://www.chinameditech.com .
Safe Harbor Statement
This press release contains forward-looking statements. These statementsconstitute "forward-looking" statements within the meaning of Section 21E ofthe Securities Exchange Act of 1934, as amended, and as defined in the U.S.Private Securities Litigation Reform Act of 1995. These forward-lookingstatements can be identified by terminology such as "will," "expects,""anticipates," "future," "intends," "plans," "believes," "estimates" andsimilar statements. Such statements involve certain risks and uncertaintiesthat could cause actual results to differ materially from those in theforward-looking statements. Further information regarding these and otherrisks is included in the Company's filings with the U.S. Securities andExchange Commission, including its annual report on Form 20-F. The Companydoes not undertake any obligation to update any forward-looking statement as aresult of new information, future events or otherwise, except as requiredunder applicable law.For more information, please contact: Winnie Yam Tel: +852-2511-9808 Email: IR@chinameditech.com
SOURCE China Medical Technologies, Inc.