WALTHAM, Mass. (USA) and Shanghai, China - April 15, 2015 - PerkinElmer, Inc., a global leader focused on improving the health and safety of people and the environment, today announced that it has received market authorization from the China Food and Drug Administration (CFDA) to offer its Genetic Screening Processor® (GSP) instrument and GSP Neonatal hTSH reagent kit.
The GSP is a fully automated, high throughput analyzer that tests neonatal dried blood spot samples to detect potentially life-threatening conditions in newborn babies. The GSP Neonatal hTSH reagent kit aids specifically in the detection of congenital hypothyroidism. The GSP instrument is capable of testing for a wide range of disorders using PerkinElmer's dried blood spot assays on a single platform.
The CFDA's market authorization for the GSP instrument and GSP Neonatal hTSH reagent kit is the first step in bringing a broader menu of GSP assays to China. This efficient workflow enables lab professionals to identify newborns at risk of developing a disorder so further confirmation testing may occur.
"We are committed to developing innovative solutions to help newborn screening labs in China respond to rising birth rates and expand access to testing for serious health risks in newborn babies," said Johnson Zhang, Vice President and General Manager, Diagnostics, Asia-Pacific for PerkinElmer. "As China seeks to improve the efficiency of newborn screening and reduce false positive and false negative rates, our advanced detection technologies are designed to deliver highly reliable results for better outcomes."
The GSP instrument is expandable to allow laboratories to automate every stage of an assay, from specimen reception to results reporting. In addition, PerkinElmer's informatics software provides improved automation of the newborn screening process by enabling integration of additional assays, analytical instruments and punchers onto the GSP's platform.
PerkinElmer is a global diagnostics leader specializing in neonatal and prenatal screening and infectious disease detection through its comprehensive portfolio of instruments, kits and software. The Company has screened 486 million babies worldwide, and in China, it has relationships with more than 400 prenatal and neonatal screening centers and over 2,000 infectious disease screening laboratories throughout the country.
To learn more about PerkinElmer's GSP instrument and GSP Neonatal hTSH reagent kit, please click here.
About PerkinElmer, Inc.
PerkinElmer, Inc. is a global leader focused on improving the health and safety of people and the environment. The Company reported revenue of approximately $2.2 billion in 2014, has about 7,700 employees serving customers in more than 150 countries, and is a component of the S&P 500 Index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.