China Medical Technologies Receives SFDA Approval For Its Bladder Cancer FISH Probe

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology;  Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 28 Apr 2009 - 1:00 PDT

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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 has received approval for its Bladder Cancer FISH Probe (the "Probe") from the State Food and Drug Administration (the "SFDA") in the People's Republic of China.

The Probe is an advanced molecular diagnostic test kit that uses DNA probes for early detection and monitoring the course of bladder cancer. It is designed to detect and identify whether aneuploidy for chromosomes 3, 7, 17 and loss of the p16 locus are present in the human bladder cells. A number of hospitals in China have applied the Probe for diagnosing patients with hematuria and have diagnosed patients with early-stage bladder cancer as well as early-stage ureteral cancer, which caused hematuria in these patients.

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 (IVD) products using Enhanced Chemiluminescence (ECLIA) technology, Fluorescent in situ Hybridization (FISH) technology and Surface Plasmon Resonance (SPR) technology to detect and monitor various diseases and disorders.

Source: China Medical Technologies, Inc