Life Technologies gains Canadian, Mexican regulatory approval of genetic analyzers

May 23, 2013

Life Technologies has announced that its Applied Biosystems 3500 Dx/3500xL Dx Genetic Analyzers CS2 have been approved by Health Canada for diagnostic use. The analyzers have also been approved by the Federal Commission for Protection against Health Risks in Mexico for diagnostic use. The developments mark a major extension of Life Technologies' capabilities to serve the clinical market in North America with Sanger-based solutions.

In February 2013, the 3500 Dx/3500xL Dx Genetic Analyzers CS2 Series received U.S. Food and Drug Administration (FDA) 510(k) clearance for use with the company's SeCore HLA typing kits. Additional products offered by Life Technologies for the molecular diagnostics lab market in Canada include the Applied Biosystems 7500 Fast Dx Real-time PCR instrument and the QuantStudio Dx Real-time PCR Instrument, both available as Class I devices.

According to company spokespersons, the Applied Biosystems 3500 Dx Series Genetic Analyzers deliver higher throughput and increased productivity for clinical laboratories. Noting that the 3500xL Dx is an automated 24 capillary-based Sanger Sequencer, while the 3500 Dx is an eight-capillary instrument, they stress that by offering both, the company is providing hospitals of varying sizes the flexibility they need to meet their throughput demands, designed for a wide range of sequencing applications. In addition to diagnostic use, the instruments are appropriate for a wide range of research applications, including de novo sequencing and mutational profiling. Read more about these analyzers in a product specification sheet.