The United States Department of Health and Human Services has awarded WuXi’s genome center CLIA (Clinical Laboratory Improvement Amendments) status. We caught up with Hongye Sun, VP and CTO of WuXi’s Genomics Center, to get the lowdown on the news.
QUESTION: What does the CLIA certification mean to WuXi and its clients?
SUN: We are now the first CLIA certified genomics clinical laboratory in China. It allows us to participate more fully in one of the most exciting areas of drug development. Gene sequencing is opening our eyes to the underlying causes of disease, and helping identify better ways to treat illnesses. As a CLIA-certified lab, we can support our partners in this mission by running clinical trial gene sequencing projects. No other lab in China has the certification to offer this service.
QUESTION: What was the process for winning CLIA certification?
SUN: The early planning dates back to before the genomics center opened in 2011. We foresaw clinical gene sequencing becoming ever more important, so installed CLIA-level quality management systems and worked to validate a number of assays. It culminated in U.S. government audit recognizing our efforts and granting us CLIA certification.
QUESTION: How does the clinical gene sequencing service complement WuXi’s other offerings?
SUN: It really continues our efforts to build an industry leading open-access technology and capability platform. Anyone can leverage these capabilities to discover and develop therapeutic products to benefit patients. It’s exciting that we can put that power in the hands of more people, and ultimately it furthers our main goal – to improve patient care.