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China Medical Technologies Receives SFDA Approval for its Leukemia FISH probe
Nov 09, 09 07:00AM
BEIJING, Nov. 9 /PRNewswire-Asia-FirstCall/ -- China Medical Technologies, Inc. (the "Company") (Nasdaq: CMED - News), a leading China-based medical device company that develops, manufactures and markets advanced in-vitro diagnostic products, today 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 ("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.
As of today, the Company has received SFDA approvals for all the major FISH probes that the Company acquired as part of the FISH business in March 2007, which include HER-2 FISH Probe, Prenatal FISH Probe, Cervical Cancer FISH Probe, Bladder Cancer FISH Probe and Leukemia BCR/ABL FISH Probe. The FISH probes that the Company developed after its acquisition of the FISH business in March 2007, such as 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.
"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 Chief Executive Officer of the Company. "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."
About China Medical Technologies, Inc.
China Medical Technologies is a leading China-based medical device company that develops, manufactures and markets advanced in-vitro diagnostic (IVD) products using Enhanced Chemiluminescence (ECLIA) technology, Fluorescent in situ Hybridization (FISH) technology and Surface Plasmon Resonance (SPR) technology to detect and monitor various diseases and disorders. For more information, please visit http://www.chinameditech... .
Safe Harbor Statement
This press release contains forward-looking statements. These statements constitute "forward-looking" statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Further information regarding these and other risks is included in the Company's filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.