Agilent Technologies Inc. has announced that the China Food and Drug Administration has approved the company’s SureScan Dx microarray scanner as a medical device for in vitro diagnostic use.
“Bringing microarray scanning technology to clinical-quality standards is an important milestone in moving the advancement of genome-wide chromosome analysis to the clinic,” said Dr. Richard Choy, associate professor at the Chinese University of Hong Kong. “Agilent’s SureScan Dx scanner offers high resolution and sensitivity as well as dynamic autofocus to correct for differences in slide thickness. This means high-quality data for analysis.”
The product is CE marked for in vitro diagnostic use in Europe. It is approved for in vitro diagnostic use in South Korea and Singapore.
The SureScan Dx microarray scanner comes with an autoloader and Agilent Microarray Scan Control software. The system measures fluorescence signals from labeled DNA and RNA targets hybridized to microarrays, for example, to compare two DNA samples for differences.
“Agilent is committed to offering quality, precision measurement equipment to clinical laboratories worldwide,” said Peter Serpentino, Agilent vice president and general manager for Genomics. “We are pleased to introduce the SureScan Dx scanner in China for use in clinical laboratories.”