China Medical Technologies Receives SFDA Approval for Breast Cancer HER-2 ...( - the First SFDA Appro...)

- 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."

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