Life Technologies Initiates Clinical Trials Leading to 510(k) Submission of a Class I and Class II HLA Sequence-Based Typing Solution
CARLSBAD, Calif., March 21, 2011 /PRNewswire/ -- 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 t