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China Medical Technologies Announces SFDA Approvals for its Prostate Cancer FISH Detection Kit and TOP2A FISH Detection Kit

August 10, 2011

BEIJING, Aug.10, 2011 /PRNewswire-Asia-FirstCall/ — China Medical Technologies, Inc. (the “Company”) (Nasdaq: CMED), a leading China-based advanced in-vitro diagnostic (“IVD”) company, today announced that it has received approvals for its prostate cancer FISH detection kit and Topoisomerase 2-alpha (“TOP2A”) FISH detection kit from the State Food and Drug Administration (the “SFDA”) of the People’s Republic of China.

The Company has received SFDA approvals for eight FISH applications including bladder cancer FISH detection kit, cervical cancer FISH detection kit, leukemia BCR/ABL FISH detection kit, prostate cancer FISH detection kit, EGFR FISH detection kit, HER-2 FISH detection kit, TOP2A FISH detection kit and prenatal disorder FISH detection kit.

In addition, the Company has submitted applications to the SFDA for the following products:

FISH kits

  • Lymphoma
  • Miscarriage analysis
  • Myelodysplastic syndromes
  • Soft tissue sarcoma

PCR assay

  • KRAS, a diagnostic assay for colorectal cancer patients on the use of targeted cancer drugs

“We have the most comprehensive and largest SFDA-approved FISH product portfolio in China with the nearest competitor only having two SFDA-approved FISH applications,” said Mr. Charles Zhu, Senior Vice President of Operations of the Company. “We will continue to maintain this competitive edge over our competitors in the next few years and expect to receive SFDA approvals for the above FISH kits and PCR assay within the next twelve months. We believe that it will take considerable time for competitors to build a similarly broad SFDA-approved FISH product portfolio in China.”

About China Medical Technologies, Inc.

China Medical Technologies, Inc. is a leading China-based advanced IVD company using molecular diagnostic technologies including Fluorescent in situ Hybridization (FISH) and Surface Plasmon Resonance (SPR) and an immunodiagnostic technology, Enhanced Chemiluminescence Immunoassay (ECLIA), to develop, manufacture and distribute diagnostic products used for the detection of various cancers, diseases and disorders as well as companion diagnostic tests for targeted cancer drugs. The Company generates all of its revenues in China through the sale of diagnostic consumables including FISH probes, SPR-based DNA chips and ECLIA reagent kits to hospitals which are recurring users of the consumables for their patients. The Company sells FISH probes and SPR chips to large hospitals through its direct sales force and ECLIA reagent kits to small and mid-size hospitals through distributors. For more information, please visit http://www.chinameditech.com.

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 “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the quotations from management in this press release contain forward-looking 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.


    Contact

    Winnie Yam
    Tel: 852-2511-9808
    Email: IR@chinameditech.com

SOURCE China Medical Technologies, Inc.


Source: newswire