NEW YORK (GenomeWeb News) – Life Technologies said today that it has received US Food and Drug Administration 510(k) clearance for capillary electrophoresis sequencing systems and an HLA typing assay.
The company's 3500 Dx Genetic Analyzers and its SeCore HLA typing kits are the first 510(k)-cleared, sequencing-based systems for HLA typing in the US, the firm noted.
"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," Ronnie Andrews, Life Tech's president of medical sciences, said in a statement. "The instrument was designed with the clinical laboratory in mind, featuring a novel design that incorporates the ability to track reagent usage with radio frequency identification (RFID) tags, as well as redesigned data collection and analysis software."
As reported by GenomeWeb Daily News sister publication Clinical Sequencing News, the company submitted its machine and assay for clearance two years ago. The HLA test covers six genes within the major histocompatibilty complex, including the Class I genes HLA-A, HLA-B, and HLA-C, as well as the Class II genes DRB1, DQB1, and DPB1.
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 machine is also CE-marked for in vitro diagnostic use in Europe and has been approved by China's State Food and Drug Administration for diagnostic use.
Life Tech also plans to submit its Ion Torrent PGM next-generation sequencing machine for 510(k) clearance this year.
"We will continue to aggressively pursue a regulatory pathway for our leading technologies in the clinical space, including next-generation sequencing," Life Tech Chairman and CEO Greg Lucier said in the statement.