The genomics clinical laboratory in Shanghai of WuXi PharmaTech, a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, has successfully passed the survey by the Centers for Medicare and Medicaid Services of the U.S. Department of Health and Human Services relating to CLIA (Clinical Laboratory Improvement Amendments) standards, thereby receiving CLIA certification. WuXi's laboratory is the only CLIA-certified clinical laboratory in China.
CLIA standards, established by the U.S. Congress in 1988, relate to all clinical laboratory testing on specimens derived from humans in the United States to give information for the assessment, diagnosis, prevention, and treatment of disease or other impairment of health. The objective of CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test is performed. Receipt of a CLIA certificate allows WuXi's genomics laboratory to undertake certain clinical trial gene sequencing projects.
"We are excited about the addition of CLIA-certified clinical laboratory testing to our suite of service offerings," said Dr. Ge Li, CEO of WuXi AppTec. "WuXi is dedicated to the highest operational and quality standards. Our CLIA certification is an important milestone in realizing our vision to build an open-access technology and capability platform that enables anyone and any company to discover and develop therapeutic products to benefit patients."
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