US-based Agilent Technologies has received approval from China Food and Drug Administration for its SureScan Dx microarray scanner, as a medical device for in-vitro diagnostic use.
SureScan Dx microarray scanner received CE Mark approval for in-vitro diagnostic use in Europe, as well as in South Korea and Singapore.
Chinese University of Hong Kong associate professor Dr Richard Choy said: "Bringing microarray scanning technology to clinical-quality standards is an important milestone in moving the advancement of genome-wide chromosome analysis to the clinic.
"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 microarray scanner, which features an autoloader and Agilent Microarray Scan Control software, is intended to measure fluorescence signals from labelled DNA and RNA targets hybridised to microarrays, to compare two DNA samples for differences.
The scanner system was validated for use with Agilent G3 Gene Expression and cytogenetic microarrays.
Agilent Technologies vice-president and Genomics general manager Peter Serpentino said: "Agilent is committed to offering quality, precision measurement equipment to clinical laboratories worldwide.
"We are pleased to introduce the SureScan Dx scanner in China for use in clinical laboratories."
The company provides instruments, software, services, and consumables for laboratory workflow in 100 countries.