China Medical Technologies Receives SFDA Approval for its PCR-based KRAS Assay for Colorectal Cancer Targeted Drug
BEIJING, Oct. 13, 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 China’s State Food and Drug Administration (the “SFDA”) has approved the Company’s real-time PCR-based V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (“KRAS”) assay (the “PCR KRAS Assay”) as a companion diagnostic test for the use of a targeted drug for the treatment of colorectal cancer patients.
The PCR KRAS Assay is a diagnostic assay used for the detection of specific mutations in the KRAS gene using a real-time PCR analyzer. It predicts which colorectal cancer patients are likely to respond to and benefit from the targeted drug. About 60% of colorectal cancer patients have a non-mutated KRAS gene, while the remaining colorectal cancer patients with mutations may not be responsive to the targeted drug.
According to the Chinese Ministry of Health, colorectal cancer is one of the most common digestive tract cancers. About 170,000 new colorectal cancer cases were diagnosed each year in China, and the incidence rate is expected to increase.
The PCR KRAS Assay expands the Company’s SFDA approved product portfolio of companion diagnostic tests for targeted cancer drugs. The product portfolio currently includes FISH HER-2 kit for breast cancer targeted drug and stomach cancer targeted drug, FISH BCR/ABL kit for leukemia targeted drug, FISH EGFR kit and PCR EGFR assay for non-small cell lung cancer targeted drug as well as the newly approved PCR KRAS assay for colorectal cancer targeted drug. The Company plans to continue focusing on expanding its product portfolio.
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. 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.