- the First SFDA Approved FISH Probe in China
BEIJING, Nov. 12 /Xinhua-PRNewswire-FirstCall/ -- China Medical Technologies, Inc. (the "Company") (Nasdaq: CMED), a leading China-based medical device company that develops, manufactures and markets advanced in-vitro diagnostic products, today announced that the Company received approval for its Breast Cancer HER-2 FISH probe (the "HER-2 FISH probe") from the State Food and Drug Administration ("SFDA") in China.
The HER-2 FISH probe is designed to detect amplification of the HER-2 gene in human breast cancer tissue. HER-2, also known as HER-2/neu, is a gene that is notable for its prognostic role as well as the target of Herceptin, a drug for breast cancer treatment. Herceptin is effective in cancer patients whose HER-2 gene is over-expressed.
"We are excited to be the first company in China to receive SFDA approval for our FISH probes," said Mr. Xiaodong Wu, Chairman and CEO of the Company. "The approval enables us to initiate commercial promotion of our FISH probes. We believe that the commencement of commercial promotion will increase public awareness of the clinical benefits of FISH probes, which in turn will result in long term sustainable growth of the recurring sales of our FISH probes. In addition, hospitals can apply for the inclusion of the FISH test in the medical insurance reimbursement schemes in their respective province. From our experience of obtaining the first SFDA approval for the HER-2 FISH probe, we are confident in getting SFDA approvals for our other FISH probes and molecular diagnostic products on a timely basis."
Safe Harbor Statement
This press release contains forward-looking statements. These statements constitute "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and 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. 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.
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 products using Enhanced Chemiluminescence (ECLIA) technology and Fluorescent in situ Hybridization (FISH) technology, to detect and monitor various diseases and disorders, and products using High Intensity Focused Ultrasound (HIFU) for the treatment of solid cancers and benign tumors. For more information, please visit http://www.chinameditech.com .
For more information, please contact:
Winnie Yam
Tel: +86-10-6530-8833
Email: IR@chinameditech.com