Life Technologies Corp’s Applied Biosystems 3500 Dx Genetic Analyzer has been approved by China’s State Food and Drug Administration (SFDA) for diagnostic use in China. The 3500 Dx is a capillary-based Sanger Sequencer intended for use in the analysis of human DNA or RNA for the detection of genetic changes that may lead to disease presence or susceptibility.
“Approval by SFDA means that hospital laboratories and patients across China will benefit from the accuracy and reliability of the 3500 Series platforms,” said Siddhartha Kadia, President of Life Technologies, Greater China. “A number of diagnostic applications could be developed for the 3500, such as infectious disease and virus detection, genetic disease and cancer mutation identification for targeted drug therapies, as well as prenatal chromosome disorder detection.”
The 3500 Dx instruments were designed with clinicians in mind, featuring a consumables design that incorporates the ability to track information with radio frequency identification (RFID) tags, new optical and thermal sub-systems, as well as redesigned data collection and analysis software, creating a cost-effective method for sample analyses. Depending on the degree of multiplexing, the 3500 Dx Series can run up to 1,100 sequencing or 1,200 genotyping samples per day.
The 3500 Dx instruments are CE-marked for in vitro diagnostic use in Europe and are also available in Japan, Australia, India, New Zealand, Singapore, and Taiwan. In August 2011, the 3500 Dx was submitted to the FDA, along with the company’s Invitrogen SeCore® HLA Sequencing System for HLA typing, an essential component of determining organ and bone marrow transplant compatibility between donors and patients. In May 2011, Life Technologies announced a partnership with Gen-Probe, Inc. for development of diagnostic assays for the platform, and continues to seek additional partners to develop the assay menu.
Source: Life Technologies Corp
