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news.China Medical Technologies, a medical device company, has received approval for its breast cancer HER-2 FISH probe from the State Food and Drug Administration in China.
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According to the company, the HER-2 fluorescent in situ hybridization (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 said to be effective in cancer patients whose Her-2 gene is over-expressed.
Xiaodong Wu, chairman and CEO of China Medical Technologies. “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.”