CRO WuXi PharmaTech, with operations in China and the U.S., said its genomics clinical laboratory in Shanghai has successfully passed the survey by the Centers for Medicare and Medicaid Services of the HHS 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 lab testing on specimens derived from humans in the U.S. 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 lab to undertake certain clinical trial gene sequencing projects.