Covance Supports Chinese Regional Laboratory in Achieving Level 1 NGSP Certification
Center of Laboratory Medicine, Hua Shan Hospital in Shanghai distinguished as only NGSP Level 1 laboratory in China linked to global clinical trial network
Princeton, NJ – July 18, 2005 – Covance Inc. (NYSE: CVD) today announced that the Center of Laboratory Medicine, Hua Shan Hospital, Shanghai, China, working with Covance's Central Laboratory Services unit, has been certified as a Level 1 laboratory testing facility by the National Glycohemoglobin Standardization Program (NGSP) of the United States.
In China, which is a key location for clinical trials - including those related to the treatment of diabetes - Covance utilizes the Hua Shan Hospital's Center of Laboratory Medicine as a regional laboratory service provider to meet biopharmaceutical sponsors' in-country testing needs. With this certification, sponsors are assured that their Covance clinical trial specimens are tested in a global network of NGSP Level 1 certified laboratories – in China, as well as in Sydney, Australia; Singapore; Geneva, Switzerland; and Indianapolis, Indiana in the United States. The Hua Shan Hospital Laboratory is distinguished as China's only NGSP Level 1 laboratory that is linked to a global network of clinical trial laboratories, facilitating the collection of a unified, combinable set of laboratory test results.
"NGSP Level 1 certification is a standard requirement for hemoglobin A1C testing for drug development for diabetes research," said Gordon F. Kapke, Ph.D., Vice President, Global Technical Affairs for Covance Central Laboratory Services. "The certification of Hua Shan Hospital's Laboratory overcomes the limitations caused by China's export restrictions on whole blood, and allows investigator sites in China to be included in broader regional and global clinical trials."
NGSP Level 1 Laboratory certification for hemoglobin A1C (HbA1C) standardizes glycohemoglobin (GHb) test results, so clinical trial results from various central and regional laboratories are comparable globally to those reported in the landmark Diabetes Control and Complications Trial*. This study showed that control of patient blood glucose levels slows the onset and progression of eye, kidney, and nerve diseases caused by diabetes. The World Health Organization estimated that over 20 million people in China suffered from diabetes in 2000 - a number which is expected to grow to over 42 million by 2030.
In the last three years, Covance Central Laboratory Services has managed over 470 studies across the Asia-Pacific region, involving more than 3,500 investigator sites and over 31,600 patients. Within the region, Covance has addressed the limitations around the transportation of whole blood out of China, by working with the Hua Shan Hospital's Center of Laboratory Medicine, to provide high-quality laboratory services in-country. In China alone, Covance has managed over one hundred investigator sites and more than 2,200 patients. NGSP certification of the Hua Shan Hospital regional laboratory follows last year's expansion of Covance's Singapore Central Laboratory to support Nucleic Acid Amplification testing, as part of Covance's ongoing development of laboratory testing services for clinical trials in the Asia Pacific region.
Covance Inc., with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with annual revenues greater than $1 billion, global operations in 17 countries, and approximately 6,800 employees worldwide. Information on Covance's products and services, recent press releases, and SEC filings can be obtained through the Covance website at www.covance.com
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* http://diabetes.niddk.nih.gov/dm/pubs/control/
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