Shanghai, March 28, 2013 -Life Technologies CorporaTIon today announced that its 3500xL Dx series of genetic analyzers from American Applied Biosystems has been approved by the China Food and Drug Administration (SFDA) and will be used in China clinical diagnosis. At the same time, it announced that its joint venture with Da'an Genome has launched 10 detection kits. This progress marks a significant improvement in Life Technologies' ability to use capillary electrophoresis-based solutions to serve the Chinese clinical end market.
The 3500xL Dx series is an automated Sanger sequencer based on a 24-channel capillary and is used for sequencing a variety of genes. It can provide high-quality performance, higher throughput and work efficiency for clinical laboratories around the world.
Including the 3500 Dx gene analyzer approved by China's State Food and Drug Administration in 2011 for in vitro diagnostics, Life Technologies' 3500 series gene analyzers can be used for many types of numerous applications in clinical research, including de novo sequencing and mutation Analysis and HLA typing. The new additions to the 3500 Dx and 3500xL Dx series provide hospitals of all sizes with the flexibility they need to meet the requirements of testing different numbers of samples.
Guangzhou Lifei Daan Diagnostic Products Co., Ltd. has developed or authorized 10 test kits based on the 3500 Dx series platform. This company is a joint venture company established by Life Technologies and Sun Yat-sen University Daan Gene Co., Ltd. in 2012. These detection kits will be used for genotype resistance detection, cancer mutation identification and prenatal chromosomal abnormality detection. Currently, 9 of these 10 kits are for research use only, and another test method has been registered with China's State Food and Drug Administration for prenatal screening to detect Down syndrome during trisomy 21. The company is currently actively conducting clinical trials with a view to obtaining approval from China's State Food and Drug Administration for nine additional products.
The 3500xL Dx series is currently approved by China's State Food and Drug Administration, which not only exemplifies the success of Life Technologies' efforts in the market compliance of laboratory diagnostic instruments, but also highlights our vision to become a global leader in the diagnostic industry.
Ronnie Andrews, President of Life Technologies ’Medical Sciences Division, said:“ The 3500xL Dx series is currently approved by the China Food and Drug Administration, which not only exemplifies the success of Life Technologies ’efforts to market compliance of laboratory diagnostic instruments, but also highlights our dedication Yu's vision to become a global leader in the diagnostic industry. "
"Like other emerging countries, China is also facing severe challenges in dealing with infectious diseases such as hepatitis B, tuberculosis, hepatitis C and AIDS, as well as various genetic diseases such as lung cancer, breast cancer and ovarian cancer. Early detection and treatment of these diseases will Dr. Siddhartha Kadia, President of Life Technologies Greater China, said greatly improved the chances of patients' cure and survival. "Life Technologies is committed to developing more medical diagnostic products such as 3500xL Dx series genetic analyzers to support clinical research and diagnosis, which will also create a better life for the Chinese people and help build more economies Affordable healthcare solutions. "
The Sanger sequencer of American Applied Biosystems has provided technical support for the Human Genome Project. The Sanger sequencing method has always been regarded as the "gold standard" in the field of sequencing due to its accuracy, reliability and ease of use. The application of sequencing technology in the field of clinical diagnosis is reshaping the worldwide disease treatment model.
Life Technologies ’other products for the Chinese diagnostic laboratory market include: Applied Biosystems’ Applied Biosystems ’7500, 7500 Fast Dx, StepOne, StepOne Plus, and ViiA7 Dx qPCR series. VeriTI ™ Dx thermal cycler is applying for registration by China National Food and Drug Administration.
About Life Technologies
Life Technologies CorporaTIon (NASDAQ: LIFE) is a global biotechnology company dedicated to providing the most innovative products and services to leading customers in scientific research, genetic analysis, and applied sciences. The company operates in more than 180 countries and regions, has 50,000 end-to-end solutions, is protected by more than 5,000 patents and licenses, and spans the entire field of biotype spectrum, including scientific exploration, molecular diagnostics , 21st century forensic identification, regenerative medicine and agricultural research. Life Technologies has approximately 10,000 employees and 2012 sales of US $ 3.8 billion. For more information, please follow the Life Technologies Weibo homepage.
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