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Life Technologies Receives FDA 510(k) Clearance for Diagnostic Use of Sanger Sequencing Platform and HLA Typing Kits
Date:2/11/2013

home/Products-and-Services/Applications/Diagnostics-Clinical-Research/Transplant-Diagnostics/HLA-Transplant-Diagnostics-Platforms/SeCore-HLA-Sequencing/uTYPE-HLA-Sequencing-Software.html?CID=fl-utype">uTYPE® Dx HLA Sequence Analysis Software constitute the first 510(k)-cleared, sequence-based system for HLA typing in the United States. Tissue typing is an essential component of determining compatibility between donors and patients for organ and bone marrow transplantation. HLA typing on the 3500 Dx offers labs an optimized, streamlined workflow with higher resolution than other molecular HLA typing technologies such as sequence-specific oligonucleotide (SSO) methods. 

"With clearance of this system, transplant patients can now have the confidence that their HLA tissue typing was performed utilizing a thoroughly tested, high resolution technique that has passed the strict test requirements of the FDA," said Ronnie Andrews , president of medical sciences at Life Technologies. "Precise HLA matching between donor and patient significantly improves overall transplant survival."

The 3500 Dx is now the only 510(k)-cleared Sanger sequencer commercially available for the diagnostics market. Sanger, also known as capillary electrophoresis, sequencing is the technology that powered the Human Genome Project and remains the "gold-standard" for its accuracy, reliability and ease of use.  It is expected that clearance will facilitate development of additional assays using the 3500 Dx and open up new partnerships with assay developers.

"Sanger sequencing remains the gold standard for providing the reliable results clinical labs need, and 510(k) clearance of the 3500Dx will help to establish sequencing technology as a mainstay of the hospital lab," said Andrews. "The instrument was designed with the clinical
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SOURCE Life Technologies Corporation
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