China Medical Technologies Receives SFDA Approval for its First Self-Developed PCR-based EGFR Assay for Lung Cancer Targeted Drugs
BEIJING, Nov. 10, 2010 /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 approval for its real-time PCR-based Epidermal Growth Factor Receptor (“EGFR”) Assay (the “EGFR PCR Assay”) for the use of lung cancer targeted drugs from the State Food and Drug Administration of China (the “SFDA”).
The EGFR PCR Assay is used for the detection of the 28 most common somatic mutations in the EGFR gene of patients with non-small cell lung cancer (“NSCLC”) and provides a qualitative assessment of mutation status to determine the use of lung cancer targeted drugs for patients.
With its own internal research and development efforts, the Company has successfully developed its first PCR-based assay related to companion diagnostic tests for personalized medicines for cancer patients. The Company’s EGFR PCR Assay is the first PCR-based EGFR assay for the use of lung cancer targeted drugs approved by the SFDA.
“We plan to offer more products on our PCR platform to our top tier hospital customers served by our direct sales network,” commented Mr. Xiaodong Wu, Chairman and Chief Executive Officer of the Company. “As of today, the Company offers a comprehensive portfolio of molecular diagnostic products including FISH probes, SPR-based DNA chips and PCR-based assays. We believe we can further expand these three technology platforms by offering more products on each platform. In addition, we will leverage our direct sales network, which covers over 400 top tier hospitals in China, to promote our new products which have important clinical benefits and good market potential.”
Lung cancer is one of the most common cancers in the world and it is the leading cause of cancer death in China. It is estimated that more than 500,000 new lung cancer cases were diagnosed each year in China and the incidence rate of lung cancer is expected to continue to increase. According to publications in medical journals, EGFR abnormalities have been found in approximately 85% of NSCLC patients responsive to Iressa and Tarceva, two commonly used drugs for the treatment of patients with NSCLC.
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 “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.
Contact Winnie Yam Tel: 852-2511-9808 Email: IR@chinameditech.com
SOURCE China Medical Technologies, Inc.