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China Medical's SPR-based IVDs pass SFDA quality test

Singapore, Mar 26, 2009: China Medical Technologies has received quality testing certificate for its SPR-based Analysis System from one of the Chinese State Food and Drug Administration (SFDA) Quality Supervision and Testing Centers.

China Medical Technologies uses SPR (Surface Plasmon Resonance) technology to manufacture in vitro diagnostic (IVD) products.

Mr Xiaodong Wu, Chairman and CEO of the company, said, “The receipt of the certificate marks an important milestone during the SFDA approval process for our SPR System. We will continue to work on the approval process which includes the commencement of 120 clinical trial samples by three SFDA authorized Tier-one hospitals and subsequent administrative procedures by the SFDA before its approval.”

Mr Wu further said the company has commenced the clinical trial for HPV-DNA Biosensor Chip. Another three SFDA authorized Tier-one hospitals have collected over 1,000 clinical samples required for conducting the clinical trial of HPV-DNA Biosensor Chip. The hospitals have processed about one-third of the samples and would continue to finish the remaining samples to submit the results for the SFDA approval process.

The company expects to receive the respective SFDA approval for SPR System and HPV Chip before the end of 2009.

© BioSpectrum Bureau
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