Life Technologies enters clinical trials for DNA SBT platform for analysis of Human Leukocyte Antigen system

Life Technologies Corporation (Nasdaq: LIFE) today announced that it is the first life science tools provider entering clinical trials to prove the safety and effectiveness of their DNA sequence-based typing (SBT) platform for analysis of the Human Leukocyte Antigen (HLA) system.  Submission for 510(k) clearance of this SBT platform will follow completion of the clinical trials, which is anticipated this summer.  

Life Technologies has contracted a clinical research organization to oversee the clinical trials at independent, accredited HLA typing laboratories in the United States.  The laboratories will evaluate six gene regions of the HLA system using the company's Applied Biosystems™ 3500 Dx Genetic Analyzer, SeCore® kits, and uTYPE® Dx Software.  

HLA typing is one of the main determinants used in patient-donor compatibility selection for individuals diagnosed with leukemia and other blood cancers, where bone marrow transplantation can be a viable treatment option.  Located on chromosome six, the HLA gene family is the most variable gene in the human genome.  HLA typing is the process of precisely identifying these gene variations.

"As the observation of new HLA variants continues at a significant rate, using a robust SBT system is the most accurate method to keep pace with these rapid discoveries," said Todd Laird, Vice President and General Manager of Life Technologies Fragment and Sequence Genomics Division.  "Sequence-based analysis enabled by the 3500 Dx system coupled with SeCore kits is the only available technique that identifies more than 5500 gene variants at the nucleotide level, resulting in the most accurate and unambiguous assay."

"Our intention is to complete clinical trials and pursue 510(k) clearance of the 3500 Dx system and SeCore kits to demonstrate the utility of capillary electrophoresis and sequence-based assays as powerful tools in the molecular diagnostic laboratory," Laird continued.  "Life Technologies recognizes the increasingly important contribution of sequence-based analysis in the evolution of molecular medicine."