Life Technologies received FDA approval for the company’s 3500 Dx Genetic Analyzers and SeCore HLA (human leukocyte antigen) typing kits. This is the first clinically available sequence-based system for HLA typing in the U.S.
HLA typing is used to identify tissue compatibility between donor and receiving patient of transplanted organs and bone marrow. The company hopes that using its series 3500 analyzers will lead to better matches and more confidence for clinicians thanks to higher resolution results compared to sequence-specific oligonucleotide (SSO) methods.
From the announcement:
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.
Products included in the current 510(k) clearance are the 3500 Dx/3500xL Dx Genetic Analyzers CS2; 3500 Dx Series Data Collection Software v1.0; SeCore® HLA Sequencing Kits; and uTYPE® Dx HLA Sequence Analysis Software. The 3500 Dx instrument is CE-marked for in vitro diagnostic use in Europe, has been approved by China’s State Food and Drug Administration (SFDA) for diagnostic use in China, and is also available in Japan, Australia, India, New Zealand, Singapore, and Taiwan.
Product page: 3500 Dx Genetic Analyzers…